Operator notes.
How we watch FDA, and how to act on what the watching returns — the method behind the product, written down. Regulatory intelligence and practice notes, never regulatory advice.
A provider letter doesn't need a recall
FDA runs a Letters to Health Care Providers channel for devices that sits apart from the recall and enforcement database, is sometimes written by FDA itself rather than the manufacturer, and carries no openFDA endpoint — a gap Congress now makes FDA count out loud, every two years, because it isn't the same instrument as a recall.
A qualified tool has a context, not a blanket
FDA's Medical Device Development Tools program lets a sponsor cite another company's already-qualified biomarker, outcome assessment, or test model by its submission number instead of re-proving it works — but only inside the exact context of use FDA qualified it for, never a wider one.
The eMDR account isn't automatic
21 CFR 803.12(a) has required medical device reports in electronic format since a 2014 final rule took effect in August 2015, but nothing about registering an establishment or clearing a 510(k) creates the FDA Electronic Submissions Gateway account that actually transmits one — that account runs its own test-submission and approval sequence, on FDA's clock, not yours.
The manufacturer who owns no factory
21 CFR 807.20 doesn't reserve the registration duty for whoever runs the production line. A company that writes a device's specifications and hands every physical step to a contract manufacturer is, in FDA's own vocabulary, a manufacturer too — a Specification Developer, named and required in the agency's own registration guidance, with its own standing in the public record.
GLP covers the safety study, not the device
21 CFR Part 58's Good Laboratory Practice rule attaches to a nonclinical safety study backing a device application — not to exploratory bench work, not to a clinical study, and, under FDA's own twelve-year-old draft guidance, not usually to an IVD study run on human specimens.
Part 11 governs the copy, not the duty.
21 CFR Part 11 only sets the conditions for trusting an electronic record. The duty to create and keep that record in the first place comes from a separate rule entirely — one FDA's own 2003 guidance never touched, and one Part 11 was never written to replace.
A K-number isn't always a 510(k)
openFDA's device/510k endpoint and its k_number field hold two legally distinct kinds of grant — a 510(k) clearance and a granted De Novo request — told apart only by a prefix. A Humanitarian Device Exemption holds neither field, because it has no openFDA endpoint of its own at all.
Approved once. Reported every year.
21 CFR 814.84 puts a recurring filing on every approved PMA automatically, due every year from the original approval date — no supplement, no inspection, and no study order required to trigger it. No public database shows whether a given year's report was ever filed.
The goal date passes. FDA owes a letter.
FDA's own guidance requires a written notice, naming the holdup and a new target date, the moment a 510(k), PMA, or panel-track supplement runs past its MDUFA goal — a document that reaches the sponsor and reaches no public record at all.
The money a 510(k) never has to mention
A 2007 law lets FDA fund nonprofit consortia that develop pediatric medical devices — and those consortia turn around and seed-fund individual device makers with that same federal money. Neither transfer has to appear anywhere near the clearance the device eventually earns.
A discussion paper isn't guidance
On August 18, 2026, CDRH's Digital Health Center of Excellence opened a 26-question docket on how to regulate generative-AI-enabled devices. The comment window closed October 19. FDA's own rules don't obligate what happens next, when it happens, or whether it happens at all.
A stereotaxic system isn't a RASD
FDA's September 2026 draft guidance gives robotically-assisted surgical devices a premarket framework for the first time — and spends nearly as much of it saying what the category excludes. Comments close November 24, 2026.
The A-list is a forecast, not a deadline.
CDRH published its FY2027 guidance priorities on October 1, 2026 — eight items on the A-list, a longer Under Construction list behind them, and a comment window open until November 30. The three tiers say which guidance FDA means to write this year. None of them say when, or whether, it will.
Ultra has a gram range. Fragrance doesn't.
FDA's absorbency vocabulary for tampons — light, regular, super, super plus, ultra — has been bound to specific test-method gram ranges since 1989, amended twice since. Ingredient and fragrance disclosure, the part of the label most of the current attention is actually about, is still a draft guidance FDA has not finalized.
Patient preference just reached the 510(k)
FDA's March 2026 guidance widens where patient preference information can inform a benefit-risk judgment — from PMA, HDE, and De Novo alone to IDE, 510(k), and Breakthrough Device requests too. The evidentiary standard those six pathways now share did not move with it.
The health hazard evaluation isn't the record
Under 21 CFR 7.41, FDA — not the firm — assigns a device recall its Class I, II, or III severity, built on an internal Health Hazard Evaluation. The enforcement record this product watches carries the resulting number and the firm's own reason for recall. It was never built to carry the evaluation that produced the number.
The sponsor proposes risk. The IRB decides.
A device study classified nonsignificant risk never reaches FDA as a filing at all — under 21 CFR 812.2(b), the reviewing IRB's approval is treated as the approved IDE. The sponsor proposes that classification. The IRB is the party the regulation actually lets decide it.
A Special 510(k) needs a predicate you own
FDA's September 2019 guidance moves a Special 510(k) through its Document Control Center in 30 days instead of 90 — and names, in the same guidance, the one condition that speed depends on: the predicate has to be a device the submitter already holds.
The flag marks the reviewer, not the result
FDA's own 510(k) data carries a Y/N field marking whether an accredited third party, not an FDA reviewer, ran the first pass under Section 523 of the FD&C Act. The field marks the channel. It says nothing about the decision at the end of it, because FDA reviews the recommendation and signs the clearance either way.
Call it fifteen. File it in thirty.
21 CFR 4.102 assigns a combination product's drug constituent two postmarketing safety reports. One keeps its name and its three-working-day clock no matter what. The other keeps its name — the fifteen-day report — while the same rule quietly doubles its deadline to thirty calendar days, on one condition only: a device application led the product to market.
The recognition number isn't the list number
A Declaration of Conformity asks for the number FDA assigned to one specific standard. FDA's own periodic notices carry a different number, for an entirely different thing — a batch of changes, published a few times a year, that only sometimes includes the one you're citing.
The letter to file isn't in the guidance
FDA's 2017 guidance on deciding whether a device change needs a new 510(k) names exactly two endpoints — submit, or document the basis for not submitting. “Letter to file” is the industry's own name for the second one; the guidance never uses the phrase.
The PMA preempts. The 510(k) doesn't.
21 U.S.C. § 360k(a) bars a state from imposing a device requirement that is different from or additional to a federal one — and the Supreme Court has tied that bar to the pathway, not the device. PMA approval preempts state tort claims. 510(k) clearance, as a rule, doesn't. De Novo is still being litigated.
Cleared doesn't code. Coded doesn't cover.
FDA marketing authorization, a CMS HCPCS Level II billing code, and a Medicare coverage determination are three separate decisions, made by two different agencies, on three different clocks. A device can clear every one of FDA's bars without having cleared any of CMS's.
Exempt from 510(k). Restricted anyway.
Most analyte specific reagents are Class I and exempt from premarket notification under 21 CFR 864.4020 — but the same regulation carves out Class II and Class III subsets that aren't, and every exempt ASR is still a restricted device under FD&C Act Section 520(e), sellable only to the narrow list of buyers 21 CFR 809.30 names.
Exempt from registration. Not from 510(k).
21 CFR 807.65(d) exempts a licensed practitioner from registering an establishment when a device is made solely for their own practice, under Section 510(g) of the FD&C Act. Section 510(k), the premarket notification duty, sits in the same section of the same statute and answers a different question entirely.
Right to try reaches drugs, not devices
The federal Right to Try Act lets a patient obtain an unapproved treatment straight from its maker, skipping FDA's own expanded-access review — but its definitions section names only a drug. Nevada's right-to-try law, enacted three years earlier, already covered a device too.
The 510(k) clears the range, not the fit
FDA's guidance on additively manufactured devices lets a single 510(k) clear a bounded range of patient-specific shapes at once — a design envelope, validated at its worst-case edges. The clearance record that results names the envelope FDA reviewed, never the one shape any particular patient actually received.
The hospital's duty runs to the maker, not FDA.
21 CFR 803.30 gives a device user facility ten working days to report a death or a serious injury. Only the death report goes to FDA as a matter of course. A serious injury goes to the device's own manufacturer first — FDA sees it only if the facility doesn't know who that is.
The predicate study isn't the waiver study.
FDA's Dual 510(k) and CLIA Waiver by Application pathway lets one submission carry a device to clearance and to waived status at once — but only when the comparison studies were designed from the first protocol for the untrained users a waiver is meant to cover.
No clinical hold for an IDE. Only disapproval.
FDA can order a clinical hold on an IND study at any point, by phone, under 21 CFR 312.42 — delay it, suspend it, until FDA lifts the order. 21 CFR 812.30 gives FDA no matching mid-study order for an IDE. It gives FDA an application decision, and a separate duty that belongs to the sponsor.
A CFG can cover a device that never came here.
FDA's Certificate to Foreign Government has always been an export certificate — it required the device to actually leave the United States. A 2022 amendment to FD&C Act section 801(e)(4) split that requirement off, and built a second certificate for devices that never do.
The symbol skips text. The glossary can't.
FDA's 2016 symbols rule lets a device label carry a standalone pictograph with no English caption next to it. The condition is a symbols glossary somewhere in the labeling, plus a separate, prominent English statement on the package itself saying where that glossary is — and the second half is the one labeling teams forget.
The label clears 812.5. The flyer doesn't.
21 CFR 812.5 governs what an investigational device's label must say. 21 CFR 812.7 is a separate rule governing what the sponsor, the investigator, and everyone acting for them is allowed to do around that device — and a compliant label proves nothing about the second one.
A 510(k) can change hands. No rule says how.
FDA tried to write a transfer procedure for 510(k) clearances in 2014 and never finished it. In June 2025 it tried again, as a fresh draft Q&A — eleven years apart, and a transaction that happens constantly still runs on no regulation at all.
A missed renewal is two violations, not one
FDA's registration and listing window runs October 1 through December 31 every year, open right now. Miss it, and the failure to register is its own prohibited act under FD&C Act 301(p) — while every device the establishment ships in the meantime is separately misbranded under 502(o), a status the late filing doesn't undo.
Drugs expire by rule. Devices by choice.
A drug's expiration date is a federal requirement, set by stability testing FDA can inspect. A device's expiration date, almost everywhere outside a handful of specific regulations, is the manufacturer's own risk call — guided by a 34-year-old guidance document FDA itself says doesn't bind anyone.
Denied the petition. Not the outcome.
FDA told a device sponsor in the spring of 2026 that its reclassification petition didn't have the evidence to support Class II. Five months later, FDA proposed reclassifying the same product code itself — and used the same notice to carve out a brand-new device type that doesn't exist in the classification regulations yet.
Starting a committee is public. Renewing isn't.
Every FDA advisory committee runs on the same federal clock — a charter that lapses two years after establishment unless renewed in another two-year block. Creating the committee takes a Federal Register notice. Renewing it doesn't require one, and the Digital Health Advisory Committee is already living past its first deadline with no such notice on the record.
A recall closes. A radiation refund doesn't.
Closing a device correction under 21 CFR 806.10 settles the device record. A radiation-emitting device can carry a second, independent duty under 21 CFR Parts 1003 and 1004 that ends in a refund, a replacement, or a free repair — not just a report to FDA.
The trial is public. The IDE isn't.
FDAAA 801 can put an interventional device trial on ClinicalTrials.gov within three weeks of its first enrolled patient. The investigational device exemption it runs under stays confidential by regulation, often for years longer.
A PMA withdrawal pays back. A 510(k) doesn't.
FDA's own fee guidance says the statute's partial refund for an early withdrawal reaches a PMA, an HDE, and a device license application. It was never extended to a 510(k).
Interoperable is a design term, not a class.
FDA's guidance on interoperable medical devices asks a submission to describe every externally-facing interface, analyze the risk of a bad data exchange, and label the result plainly. None of that creates a classification, a product code, or a review track of its own.
The category is new. The 510(k) record isn't.
FDA's May 2026 guidance sorts every device submission into one of three Human Factors Submission Categories, each with its own documentation bar. Sort into any of the three, and the public 510(k) record looks exactly the same.
The device is cleared. Not the room.
A mammography system clears through a 510(k) under its own classification regulation. The facility that puts it in a room certifies under an entirely different statute, through an accreditation-then-certification process that never touches the clearance letter at all — and neither record ever points at the other.
Classified in 2011. Excluded in 2016.
FDA classified medical device data systems as Class I in 2011. A 2016 statute removed their software half from the device definition entirely — a stronger move than enforcement discretion. FDA did not rewrite the regulation's own text to match until a 2021 rule most of the industry never noticed.
The law reached devices. The guidance hasn't.
FDORA wrote a Diversity Action Plan mandate into the FD&C Act's device section in 2022, reaching 510(k), De Novo, PMA, and IDE submissions on the same terms as drug trials. The statute also tied the requirement to a guidance FDA hasn't finished — the deadline for finishing it passed in mid-2025, and the document is still marked draft.
The label says RUO. FDA reads intent.
FDA's own regulation lets an in vitro diagnostic skip clearance by carrying a Research Use Only or Investigational Use Only label — a line drawn by regulation, not by FDA's judgment on sight. Since a 2013 guidance, FDA has treated that label as the opening claim, weighing a manufacturer's marketing, sales, and support conduct against it before accepting that RUO or IUO is what the product actually is.
Humanitarian. Not always nonprofit.
FDA's Humanitarian Device Exemption opened in 1990 on one deal: effectiveness proof waived, profit forbidden. Amendments in 2007 and 2016 broke the second half of that deal for a defined set of devices — pediatric-labeled ones first, then a second category FDA had to spell out on its own terms.
The certification has a one-year tail
Form FDA 3454 certifies that no investigator on a covered clinical study crossed 21 CFR Part 54's financial-interest thresholds. The window that certification has to speak for runs through the study and a full year past its completion — not through the date the form gets signed.
The code changed. The failure didn't.
FDA retired its own device- and patient-problem code vocabulary for MDR reports in February 2021 and replaced it with terms harmonized to IMDRF's international terminology. A trend line that crosses that date is reading two different vocabularies as if they were one.
Skip has a ceiling. Search after doesn't.
openFDA pages a result set with skip and limit, and the two parameters together can reach exactly 26,000 records before the API stops accepting the question — a documented ceiling, not a bug. A broader pull needs a different parameter entirely.
Reviewed together. Decided separately.
FDA and CMS run a program that reviews a device's PMA or De Novo file and its Medicare national coverage determination on the same clock instead of one after the other — closed to the pathway most devices use, and capped at five devices a year.
Class III. Not called for PMA.
Section 515(b) of the FD&C Act lets a preamendment device keep clearing through 510(k) after FDA classifies its type into Class III — right up until a separate, later action under 515(b) requires a PMA. Metal-on-metal hips show what happens once that action lands.
The standard for the wire, not the device
Section 514(b) of the FD&C Act lets FDA write a performance standard directly into the Code of Federal Regulations — binding by rule, not by the voluntary declaration-of-conformity track FDA revises twice a year. One example has stood since 1997: 21 CFR Part 898, keyed not to a product code or device type but to the lead wires and patient cables connecting a device to a patient.
A reference device isn't a predicate
FDA's 2014 guidance on evaluating substantial equivalence names a second role a 510(k) can cite beyond its predicate — a reference device, used to support one technological characteristic rather than the whole comparison — and calls out the one way of blending the two roles it will not accept.
A predicate checklist nobody has to follow
FDA's September 2023 draft guidance names four concrete best practices for choosing a 510(k) predicate — and three years later it still sits on FDA's own fiscal-year 2026 “Under Construction” list, with no finalization date in sight. Nothing requires a submitter to follow it yet. That is exactly why the cheap time to start is now.
The pathway that skips the predicate
FDA's Safety and Performance Based Pathway lets an abbreviated 510(k) show substantial equivalence by meeting FDA's own published performance criteria instead of testing against a predicate device — but that shortcut exists only for the device types FDA has already written the criteria for, one guidance at a time, since the pathway's 2019 final guidance.
A network FDA funds, not FDA runs
In August 2016 FDA paid a private consortium to build a real-world-evidence network for medical devices — governance, infrastructure, and all. NEST generates evidence FDA can act on. NEST itself was never a federal system, and what happens inside it is not a federal record.
Panel-recommended. Not yet classified.
FDA's classification system has three tiers — Class I, II, and III — and a status outside all of them: unclassified, for device types FDA never reviewed after the 1976 Medical Device Amendments. A June 2026 guidance update recommends five more product codes for a class, without giving any of them one yet.
The pilot that needed a statute
In 2017 FDA picked nine companies for a pilot built on a different premise than the review already on the books: appraise the organization's culture of quality, not the device, and let that appraisal substitute for parts of premarket review. The pilot's own final report, in September 2022, said the idea needed authority Congress hadn't given it.
A committee no clearance ever names
FDA's Patient Engagement Advisory Committee is the only FDA advisory committee whose voting seats are reserved for patients, caregivers, and patient advocates rather than clinicians or scientists. It doesn't review a submission, doesn't attach to a product code, and doesn't appear on any 510(k) or PMA record — established in September 2015, it didn't hold its first meeting until October 2017.
Never cleared here. Exported anyway.
Section 801(e) of the FD&C Act lets most Class I and Class II devices leave the United States with no FDA certificate at all if they meet a foreign buyer's specifications; Section 802 requires one for the narrower set — banned devices, unapproved Class III devices, performance-standard Class II devices — that couldn't be sold here. A 510(k) or PMA search will never show either kind leaving.
Built for drugs. Silent on devices.
Section 306 of the FD&C Act lets FDA debar a person from any future drug product application after a felony conviction tied to corrupting the approval process — a mechanism Congress built in 1992 after generic-drug reviewers were bribed, and never extended to device applications through three decades of device-specific amendments since.
A significant decision carries its own clock
Section 517A of the FD&C Act gives CDRH a named, timed path to appeal a Not Substantially Equivalent letter, a PMA or HDE denial, a Breakthrough Designation refusal, or an IDE disapproval — a formal review distinct from the informal Q-Sub, on a deadline that starts the day the decision is dated, not the day it's read.
The guidance that went back to draft
FDA finalized its Q&A guidance on drug and device manufacturer communications with payors in 2018, answering how a narrow safe harbor built into Section 502(a) actually works. In June 2026 FDA reopened the same guidance as a revised draft, on a comment window that has already closed, with no final replacement posted yet.
Breakthrough crosses centers. TAP does not.
FDA's Total Product Life Cycle Advisory Program is a CDRH pilot built under the MDUFA V commitment letter, scoped first to CDRH-designated Breakthrough Devices and, from FY2026, Safer Technologies Program devices. Breakthrough designation itself reaches further than that — CBER also grants it, for device-led combination products — but the TAP pilot's own scope stops at CDRH's door regardless.
Two lists decide who reviews your 510(k)
FDA's Third Party Review Program doesn't turn on one yes-or-no. Whether a device qualifies at all lives on a standalone list organized by classification regulation and product code; which accredited organization may actually perform that review is a second, separate list — and neither one is a field in openFDA.
The reprocessor holds the 510(k)
Since a 2000 FDA guidance, a third-party or hospital reprocessor of a single-use device has been treated as that device's manufacturer, not its repair shop. For most Class II reprocessed devices, the reprocessor holds its own 510(k) — often citing the original device as predicate — filed, registered, and listed under a name that isn't the original firm's.
The Rx symbol never reaches the record
21 CFR 801.109 requires a prescription device's label to carry the ‘Rx only’ symbol or a caution statement naming the licensed practitioner it's restricted to. That determination has no counterpart field in FDA's classification, 510(k), or PMA records — and FDA treats moving a device from prescription to OTC use as a change significant enough to need a new 510(k) of its own.
The disqualification list names no device
FDA can disqualify a clinical investigator from an IDE study under 21 CFR 812.119, for repeated or deliberate misconduct in any human-subject trial — device, drug, or biologic alike. The public record that tracks it is shared across all three review centers, keyed to a person's name, and carries no product code, application number, or device identifier a portfolio watch could ever match against.
The summary FDA writes, not the sponsor
Every PMA approval or denial comes with a Summary of Safety and Effectiveness Data, required by Section 520(h)(1)(A) of the FD&C Act and written by FDA itself, not the applicant. A 510(k) submitter gets to choose how much the public sees. A PMA sponsor doesn't — and neither does a PMA FDA turns down.
A missed MDR is misbranding, not a defect
A CDRH warning letter reaches for one of two statutes before it reaches for a fact — adulterated, under Section 501, when the device or how it was made falls short; misbranded, under Section 502, when required information about it wasn't given. A firm that never files a malfunction report gets the second word, not the first.
Two names on one registration, two jobs
Every foreign device establishment's FDA registration carries two separate named contacts, not one — a U.S. Agent FDA can legally treat as standing in for the firm itself, and an Official Correspondent who is simply who filed the form. The public record keeps both. Reading them as the same person misreads who FDA is actually allowed to rely on.
A K-number is public. The other isn't.
A device that clears through 510(k) because it contains a laser or an X-ray source can still owe FDA a second, independent filing under the Electronic Product Radiation Control provisions — one that ends in a number no public database, including this one, can look up.
Exempt covers the type, not the use
FDA exempts most Class I devices, and many Class II devices, from 510(k) premarket notification — but every device-classification part in the CFR carries its own numbered section spelling out exactly where that exemption stops, in language a product code's exempt flag never surfaces.
Recognized. Not published.
FDA's 2023 guidance formally recognizes the Voluntary Improvement Program, a third-party quality-maturity appraisal, and ties real regulatory opportunities to it — risk-based inspection planning, faster PMA manufacturing-change tracks. No public FDA database records which firms or sites have been appraised.
The supplement got eSTAR. The PMA did not.
FDA opened eSTAR to PMA 30-Day Notice supplements and IDE filings in September 2025, three years after the same template became mandatory for 510(k)s. An original PMA application — the filing that opens the file a supplement later amends — still has no eSTAR option at all, voluntary or otherwise.
Congress ordered a guidance, not a rule
Section 3629 of the 2022 Food and Drug Omnibus Reform Act directed FDA to revise its real-world-evidence guidance for devices on a schedule Congress set. FDA delivered the rewrite in December 2025 — and what arrived is still guidance, governed by the same non-binding status as the version it replaced.
AI-enabled is a list. Not a field.
FDA's Artificial Intelligence-Enabled Medical Devices page names every 510(k), De Novo, and PMA device its own staff could identify by reading decision-summary language for AI terms. It is the only place that status exists — no field on any openFDA endpoint a monitoring feed actually reads carries it.
The companion diagnostic list changed its name
FDA's page pairing an in vitro diagnostic with the therapeutic product it enables was, until this July, titled for two outcomes only — cleared, or approved. The current title counts four, and the change describes what the table now holds, not a relabeling of what was already there.
The master file neither of you can read
21 CFR 814.20(c) lets a supplier submit a device master file straight to FDA and authorize a manufacturer's clearance or approval to lean on it by letter alone — without the manufacturer, the public, or, unlike its drug-side counterpart, any published list ever seeing what's inside.
The condition inside the approval order
21 CFR 814.82 lets FDA write a required postapproval study straight into a specific PMA's approval order — a condition set once, at approval, tracked in its own public database with its own status vocabulary, and distinct from both the annual report every approved PMA owes and a Section 522 order FDA can issue independent of any approval at all.
The repair FDA calls manufacturing
FDA's final guidance on servicing and remanufacturing turns on one question: did the repair return a device to its original maker's own specifications, or change them? Cross that line, and 21 CFR 820.3's definition of a remanufacturer makes the repairer a device manufacturer — registration, listing, and quality system included.
Vacated in March. Filed in September.
A district court vacated FDA's Laboratory Developed Tests rule on March 31, 2025 — a ruling with no Federal Register document of its own. FDA didn't publish the rule reverting 21 CFR 809.3 until September 19, five and a half months later.
Classified. Not waived.
FDA's device classification database — the same one FDA Radar derives a product profile from — carries device class, review panel, and three yes/no flags. Whether a cleared IVD can run outside a certified high-complexity lab is a separate determination, on a separate database, under a different part of the CFR.
Emergency use isn't defined in Part 812
FDA sorts expanded access to an investigational device into emergency use, compassionate use, and a Treatment IDE — three mechanisms with three different clocks, and the term for the fastest one is defined in the IRB regulations, not the device rule.
The two-year inspection clock is gone
For device establishments, the Federal Food, Drug, and Cosmetic Act guaranteed an inspection at least once every two years — until 2012, when FDASIA rewrote the interval into a risk-based schedule with no fixed number of years attached to any facility.
The PMA clock starts at the last module
FDA lets a PMA or HDE applicant file in FDA-agreed modules instead of one complete application — but the statutory 180-day review clock, and the acceptance and filing decisions that start it, all run from the date the last module arrives, not the first.
The Q-Sub that doesn't buy you more time
FDA's Q-Submission Program runs five distinct request types, not one — and the Submission Issue Request, built for exactly the moment a deficiency letter lands, does not pause or substitute for the formal response the letter already put on a clock.
Lapsed and revoked end an EUA differently
An Emergency Use Authorization depends on a declaration underneath it — and the declaration can lapse on its own calendar, ending every EUA built on it, without FDA ever revoking a single one for anything the product did.
A recall strategy has a grade. openFDA doesn't.
21 CFR 7.42 makes a firm commit to a depth of recall and an effectiveness-check grade before FDA accepts a recall strategy — a document distinct from the health-hazard classification, and one the public enforcement record never carries.
A granted De Novo becomes a predicate.
De Novo used to require a rejection first — file a 510(k), collect a Not Substantially Equivalent letter, then ask to be reclassified. FDASIA made the direct route law in 2012, and the device that comes out the other end can become someone else's predicate.
Least burdensome changes the ask, not the bar.
Sponsors invoke ‘least burdensome’ as leverage for a lighter review. The statute defines it the other way — a limit on what FDA may ask for, with its own line, written into the law, that the underlying standard does not move.
The lab is accredited. Not the device.
ASCA lets a submission use an FDA-accredited testing lab and a shorter Summary Test Report instead of a full one. That is a paperwork change to how a submission gets reviewed, never a lower bar for what a device has to meet.
Breakthrough is law. STeP is a guidance.
Breakthrough Devices sits in a section of the FD&C Act Congress wrote in 2016. The Safer Technologies Program sits entirely in FDA guidance — and their nearly identical 60-day clocks carry different legal weight because of it.
MDSAP replaces routine. Not for-cause.
MDSAP lets one audit satisfy five regulators' routine surveillance at once. It changes nothing about the inspection FDA opens for its own reasons — for-cause, pre-approval, or a combination product's radiation-emitting component.
No field on a 510(k) says what it treats
Intended use and indications for use are legally distinct questions under FDA's own rules, and neither is a field in the 510(k) record the API actually publishes — only a product code stands in for what a cleared device is for.
Discretion is a policy. Exclusion is a statute.
FDA's January 2026 guidance revisions put a statutory device-definition carve-out and an enforcement-discretion policy side by side on the same digital-health products. One took an act of Congress to create. The other is a guidance FDA can rewrite on its own schedule.
Designated by one office. Approved by another.
A Humanitarian Use Device designation is FDA's Office of Orphan Products Development acting on a 45-day clock — a real, dated determination that precedes the HDE application CDRH later reviews, and that never becomes a Federal Register document at all.
MedSun sits beside MAUDE, not inside it
MAUDE is the adverse-event database every device monitor reads. MedSun is a second, older CDRH network of roughly 300 hospitals and clinics reporting the close calls MAUDE's mandatory threshold was never built to catch.
The five-unit device never gets a K-number
FD&C Act §520(b) exempts a device from 510(k) and PMA review entirely once a firm caps a device type at five units a year, built to a physician's order for a named patient — and the only paper trail left behind is an annual notice to FDA that never becomes a public record.
Meeting the criteria isn't a tracking order
21 CFR 821.1 sets three criteria that make a Class II or III device eligible for FDA's device-tracking program. 21 CFR 821.20 makes the eligibility irrelevant on its own — nothing is a tracked device until FDA actually issues the order.
The PMA clock doesn't stop at approval
21 CFR 814.84 makes continued approval of a PMA contingent on filing a periodic report, once a year unless FDA sets another interval, for as long as the approval stands — a filing with no supplement number, no decision date, and no row in openFDA's PMA record.
The K-number doesn't track today's device
21 CFR 807.81(a)(3) lets a manufacturer decide, in its own quality records, that a design or manufacturing change didn't rise to needing a new 510(k) — a judgment FDA never reviews before an inspection asks for it, and the public clearance record never shows either way.
A MAUDE report proves it was filed
openFDA's device-event data carries a source_type field marking who submitted each report — a manufacturer or user facility working under a legal duty defined at 21 CFR 803, or a health professional, patient, or consumer reporting voluntarily, under none. A search result renders both the same way.
Not every MDR starts with the manufacturer
Medical Device Reporting is usually read as a manufacturer's thirty-day obligation. Hospitals, ambulatory surgical facilities, and nursing homes carry their own independent MDR duty under 21 CFR 803 — one that can put a death report in front of FDA before the manufacturer even knows the event happened.
Completed. Not terminated.
A device recall's public status field carries three words, not two — Ongoing, Completed, and Terminated — and only the last one means FDA itself determined the correction actually worked, not just that the firm said it finished.
The device-ban list has three entries
Section 516 of the FD&C Act lets FDA remove a device from the market outright, not just recall it — a bar so high the agency has cleared it three times since 1976, and a court erased the most recent one before it ever took full effect.
The UDI exception has its own deadline
A device manufactured and labeled before its Unique Device Identification compliance date doesn't need a UDI added retroactively — 21 CFR 801.30 says so. The same regulation also says that exception runs out three years later, for every device it was ever granted to.
MDUFA VI is being negotiated in public
Section 738A of the FD&C Act requires FDA to consult publicly on the next device user-fee program years before it takes effect — monthly meetings with patient and consumer groups, a public meeting, a comment period, and a docket that opened this summer for a program that won't start until fiscal year 2028.
The inspection manual changed, not the rule
FDA replaced QSIT with Compliance Program 7382.850 the same day the Quality Management System Regulation took effect — the document that tells an investigator what to check during a device inspection, posted with no Federal Register notice and no advance comment period, because a compliance program isn't a rule.
The count Congress had to legislate
FDA has issued Medical Device Safety Communications for years with no CFR trigger, no compliance deadline, and no openFDA endpoint returning them — until a 2023 appropriations act forced FDA to start counting them itself, once every two years.
The small-business rate isn't retroactive
FDA's medical device user fee program runs three separate gross-receipts tests, each requiring its own annual Small Business Determination. File a 510(k) or PMA before FDA issues that number and the standard fee is owed — with no refund once the determination clears.
A detention order has no docket to read
Under 21 U.S.C. § 334(g) and 21 CFR 800.55, an FDA inspector can order a device held in place — unusable, unmoved — the same day an inspection turns up a suspected violation, with no warning letter first and no public record of it ever having happened.
PMA approvals moved off the Federal Register
FDA Radar's own taxonomy carries a category called PMA Approval, built like every other category on the assumption that a Federal Register document announces the event. Since January 2022, under FDA's own rule, none does — the approvals moved to FDA's website and the category stayed behind, empty.
A citizen petition names names
Any person can ask FDA's Commissioner, under 21 CFR 10.30, to act on a single named product or competitor — filed as a public docket, answered on a statutory 180-day clock, through a process none of FDA Radar's four sources ever reads.
A market withdrawal isn't a recall
FDA's own definitions split a firm pulling product back into three distinct actions — recall, market withdrawal, stock recovery — by whether a violation exists at all, not by severity. Only the first is built to reach the enforcement database FDA Radar reads.
Not every device letter comes from CDRH
FDA Radar's warning-letter pipeline keeps a letter only when its issuing office reads "Center for Devices and Radiological Health." A drug-led combination product's manufacturing site can draw a letter over the same design-control and CAPA failures a device-led one would — issued by CDER, and filtered out before it ever becomes an item.
Closed on one device. Open on the rest.
FDA Radar tracks a recommended action's state once per matched product, not once per document. Close it out against your lead device and the identical recommendation stays open — correctly — everywhere else the same warning letter or recall reached.
No IDE is confirmed until the PMA is
An investigational device exemption's existence is confidential by FDA's own rule until the device wins premarket approval or a product development protocol notice takes effect. Until then, the sponsor and the reviewing IRB, not FDA, decide whether an IDE even has to exist.
The remedial-action call sets the clock
Two identical device malfunctions can land on different FDA reporting clocks — thirty days under 21 CFR 803.50, five working days under 803.53. The difference isn't the malfunction. It's the manufacturer's own conclusion about whether remedial action is needed to prevent unreasonable risk of substantial harm.
Jurisdiction is a letter, not a field
Which FDA center reviews a combination product — device, drug, or biologic lead — turns on primary mode of action under 21 CFR Part 3, settled by a Request for Designation letter that never becomes part of any public classification or clearance record. Miss the 60-day deadline, and FDA's own rule hands the sponsor's own recommendation the win by default.
An address is not a footprint
The openFDA 510(k) record keeps an applicant's city, state, and country — a mailing address, not a manufacturing site. The establishment registration number 21 CFR 807.87 requires every submission to carry never reaches that record, or FDA Radar's own ingestion of it, at all.
The final rule that isn't final yet
A Direct Final Rule publishes as a finished action — an effective date, a CFR citation, done. FDA's own procedure ships every one with a second, inert document next to it: a companion proposed rule that only activates if someone files an adverse comment, and FDA Radar's own categorizer reads both documents the same way it reads an ordinary rule.
The special controls aren't in the record
A Class II product code isn't low-risk by trust — it comes with special controls, the conditions FDA requires in place of full premarket approval. Those conditions often take the written form of a named guidance document, tied to the product code by the classification order that created it, not by anything the classification database itself returns.
Exempt from GMP. Not from complaints.
FDA's classification database marks a product code gmp_exempt_flag: Y and stops there. The regulation behind that single letter carves the exemption back out for exactly two things — records and complaint files — for the codes that carry it.
The notify list isn't the shortage list
Section 506J's product-code list names roughly 285 codes whose manufacturers must warn FDA before a shortage happens. FDA's separate Medical Device Shortages List names devices FDA has already determined are short. A code on one says nothing about whether it sits on the other.
A constraint can't be skipped. A script can.
FDA Radar's single write path refuses to approve an item without a human-written urgency and recommendation — a rule the classifier cannot touch, because the schema it returns has no field for either one. The same bright line applied to the model's own prose has no such guarantee. It has a script, and a script only runs when someone remembers to.
No cron sends this. A person does.
FDA Radar's digest job writes an HTML file and a text file to disk. It does not have a send function. The last step — pasting the result into a mail client and pressing send — belongs to a person, on purpose, because that is the same step FDA's own complaint-handling rule refuses to let happen silently.
Corrected, not rewritten
FDA Radar's correction record has one write path — a new, dated row next to the item it corrects — and no code path in the product ever updates or deletes one. That is the same shape 21 CFR 11.10(e) requires of a manufacturer's own electronic-record changes: a new entry, not an edit to the old one.
Quiet is a finding, not a default
A monitor that goes silent because nothing happened and one that goes silent because nobody checked produce the identical blank inbox. FDA Radar's personalized digest states the count of documents it read before calling a week quiet — because that number is the only thing that tells the two apart.
The summary is public. The statement isn't.
A 510(k) applicant satisfies the same disclosure rule two different ways — a summary FDA posts for anyone to read, or a statement promising the same safety-and-effectiveness data to whoever asks within 30 days. The clearance record doesn't say which one a given filing chose.
A competitor's 513(g) leaves no trace
Section 513(g) lets any person ask FDA, in writing, exactly how a device is classified and what applies to it — and get a statutory answer within 60 days. FDA's own procedures keep both the question and the answer out of every public record, including the ones FDA Radar reads.
An empty response field proves nothing
FDA's warning-letter search page shows, on every row, whether a response letter and a closeout letter have been posted. A blank response-letter indicator means the firm chose not to publish one — not that none exists, and not that FDA found it wanting.
A petition is public. Its outcome isn't.
A competitor can ask FDA, under 21 CFR 860.130, to reclassify your product code — a filing FDA must make public the day it arrives. The Federal Register notice that would put it in front of a classification watch doesn't have to follow for 180 days, or ever.
The panel is a category, not a meeting
Every 510(k) FDA Radar ingests carries a line reading "Panel: Cardiovascular Devices Panel of the Medical Devices Advisory Committee" or similar — openFDA's own field, on every record. It names which specialty reviews that device type administratively. It does not mean that panel, or any panel, ever actually met to discuss this device — most clearances, and most approvals, never see one.
An accessory carries its own classification
For decades, FDA classified a device accessory the same as the device it was built for — a delivery catheter for a Class III valve went through PMA review right alongside it. A 2017 law changed the default: FDA now classifies an accessory by its own risk, which can land it on its own product code, in its own class, entirely apart from the parent device a portfolio watch was actually built to follow.
A TPLC report is a category, not a device
FDA's Total Product Life Cycle database stitches a device's premarket and postmarket record into one report — 510(k)s, PMAs, adverse events, and recalls in a single view. The key it stitches on is the product code, a generic device type shared by every maker in it, so the counts on "your" report belong to a category, not to your device.
A 522 order is a question, not a verdict
Recalls and warning letters are the signals every monitor watches. Section 522 of the FD&C Act carries an earlier, quieter one: FDA can order a manufacturer to study a device already on the market, because the agency has a safety question it cannot yet answer. The order is not a finding of harm. It is a question, filed in a public database updated every Sunday.
A PCCP change leaves no new record
FD&C Act Section 515C, added by statute in December 2022 and given final guidance in December 2024, lets FDA pre-authorize an AI-enabled device's own future software changes inside its original clearance. Implement one, and no new 510(k) gets filed — nothing in the public clearance record marks that the device changed at all.
Not every signal becomes a recall
FDA's Emerging Signals policy lets CDRH tell the public about a device safety concern it is still evaluating — before the evidence is confirmed, and often before any company has taken, or ever takes, a corrective action a recall record would capture.
eSTAR did not remove the acceptance check
FDA's Refuse to Accept review used to run after a 510(k) reached the agency. For an eSTAR submission, mandatory since October 2023, the same completeness check runs inside the template before it is ever filed — and no field in the public 510(k) record marks which way a given clearance went through.
An early alert has no recall number yet
CDRH's Early Alert pilot, expanded to every device type in September 2025, posts a likely high-risk removal or correction before FDA classifies it — before the event has a recall number, and before it reaches the Recall Enterprise System feed FDA Radar's own pipeline actually ingests.
A consent decree isn't a database row
FDA Radar's warning-letter adapter reads a structured, public database every day. A Warning Letter that goes unanswered can escalate into a federal consent decree of permanent injunction — a court order announced case by case, in a record no adapter here, or in most monitoring built like it, ever touches.
The record has no cybersecurity field
Since March 2023, a 510(k), PMA, or De Novo for a device FDA calls a "cyber device" cannot even be accepted without a software bill of materials and a vulnerability-management plan. The public clearance record that comes back afterward — FDA's own, and FDA Radar's copy of it — carries neither one.
Classification Change is not one event
FDA Radar's Federal Register categorizer sorts a device notice into Classification Change the moment its title says "classification of" or "reclassification" — the same label for a De Novo order creating a product code from nothing and a reclassification order moving an existing one to a different class.
Publication date is not effective date
Every Federal Register document carries two dates that answer different questions — when it was published, and when it takes effect. FDA Radar's own record keeps both, as two different fields. For a device rule that phases in by class over several years, neither date is the one a specific device actually has to answer to.
One event. Many recall numbers.
FDA defines a recall event as a firm's action that can cover more than one product. openFDA keeps a field for that grouping, and FDA Radar's own record keeps it too — but every count downstream is keyed to recall_number, one row per product line, not per event.
Quantity is a sentence, not a number
openFDA's device recall record carries a field FDA itself defines as the amount of defective product subject to recall. The field's type is text, written by whoever filed the report — and a quarter's worth of them cannot be added together to get a total.
How a firm told you is a field too
openFDA's recall data carries a field for how a firm first notified the public — telephone, letter, press release — kept separate from the field that says why it recalled at all. FDA Radar's own ingestion reads it and doesn't carry it into the record yet.
A RIN outlives the document number
Every Federal Register notice carries three identifiers doing three different jobs — a document number, a docket ID, and a Regulation Identifier Number. Only one of them is built to survive past the document that first used it, and FDA's own correction to its 2024 device-quality rule shows exactly which.
The docket ID is not the comments
FDA Radar's Federal Register ingestion captures a docket_ids field on every device-relevant notice. A docket ID is a pointer, not a comment count — what a rulemaking or draft guidance actually drew lives on regulations.gov, a separate system the notice only points to.
The 510(k) record doesn't name the predicate
Every 510(k) has to name its predicate device under 21 CFR 807.92. The openFDA clearance record FDA Radar ingests daily — like the public database it comes from — carries no field for it. The name is required. It just isn't queryable.
The 510(k) FDA didn't review first
The public 510(k) record can carry a field marking that an accredited third party, not FDA staff, conducted the initial review. FDA still signs the clearance. The field is real, FDA Radar already ingests it, and the record everyone reads past does not point it out.
The letter FDA doesn't have to post
FDA runs two advisory-action letters, not one. Warning Letters post to a structured database on a rule-bound cadence. Untitled Letters, issued for the same kinds of violations minus the enforcement threat, post only when FDA decides three named criteria are met — and the database a monitoring pipeline actually watches was never built to carry them.
Cleared doesn't say which track it took
FDA runs three separate 510(k) programs — Traditional, Special, and Abbreviated — each reviewing a different amount of new evidence. The public clearance record, and FDA Radar's own, keep the outcome and drop the path.
The clock stops. The calendar doesn't.
FDA's 90-day review goal is measured in FDA Days — a count that excludes both an acceptance-review hold and an Additional Information hold. The public 510(k) record keeps only the two calendar dates that started and ended the clock, not the holds in between.
Why a guessed match never reaches you
Every match FDA Radar computes between an FDA document and your product carries a provenance field: source, human, or model. The database lets only two of the three ever fire an alert — a rule poured into the schema, not remembered by hand.
The standards list never names a device
FDA revises its list of recognized consensus standards roughly twice a year, in a single Federal Register notice indexed by standard number and edition — never by product code. No device-level watch, including this one, turns that into a personal alert.
The guidance isn't in the Federal Register.
FDA's own rule requires two separate acts before a guidance document counts as issued — a notice in the Federal Register, and the guidance itself posted separately on fda.gov. The record that's easy to watch is the first act, not the second.
Filtered. Not discarded.
FDA Radar ingests every device recall and every 510(k) clearance. It pushes almost none of them to a human — the boundary between the corpus and the review queue is a single classification field, not a judgment call.
There are two recall databases, not one
openFDA publishes two separate device recall datasets, sourced and shaped differently — one carries the K-number and PMA number a recall traces back to, the other carries the classification that says how serious it was. No record in either has both.
Breakthrough status is confidential by law
Federal law lets FDA withhold whether a sponsor even requested Breakthrough Device designation, let alone whether it was granted — right up until the device wins marketing authorization. A public database has nothing to show in the meantime, by statute, not by omission.
One MAUDE report is not one malfunction
For product codes FDA has enrolled in Voluntary Malfunction Summary Reporting, a single row in MAUDE is a quarter's worth of malfunctions bundled by brand, model, and problem code — not the one event a search result implies.
A supplement number is not a track
openFDA's PMA record logs a supplement number and a free-text reason for every change to an approved device — not which of FDA's four review tracks, from a same-day call to a full panel, that change actually took.
Cleared is not approved
A 510(k) clearance and a PMA approval are findings from two different review standards, on two different forms of words — and FDA's own misbranding rule names the specific act of calling the first one the second.
Nationwide doesn't mean your building
openFDA's recall records carry a distribution_pattern field describing where a firm first shipped a device — and the field's own definition says plainly that what happens after that first shipment isn't in it.
Not every correction reaches FDA
21 CFR 806.10 requires a device correction or removal to reach FDA within ten working days — but only when it reduces a risk to health. A correction that only improves quality is exempt by the agency's own rule, recorded internally, and never becomes a public recall.
Registered. Not reviewed.
FDA's device registration and listing record can carry a 510(k) or PMA number — typed in by the company itself, once a year, on a filing FDA's own rule says does not double as a review of that number.
Contact ODE is not a pathway
FDA's own field reference for device classification documents three submission pathways and a fourth answer that isn't one — "Contact ODE," the database's own way of saying it doesn't know. A product-code lookup that hits it isn't broken; it has reached a category FDA itself left open.
Almost no recall is FDA-mandated
openFDA marks every device recall Voluntary: Firm Initiated, Voluntary: FDA Requested, or the rare FDA Mandated — three different stories about who decided, usually read as one word. The mandated label requires FDA to make a formal, written finding first, which is exactly why it almost never appears.
FDA's device names read like a card catalog
FDA's device classification database names each device category noun-first — Catheter, Continuous Flush, not continuous flush catheter — a filing convention nowhere explained and everywhere load-bearing the moment a search is typed the way a person would say it.
openFDA is free. It is not unlimited.
openFDA is free and keyless, and FDA publishes exactly how far that goes: 1,000 requests a day, 240 a minute, before the ceiling ever shows up in a script's output. A free key raises it to 120,000 — the difference between a monitor that keeps working and one that goes quiet the week a recall needs reading.
GUDID stores the model. Not the box.
A Unique Device Identifier splits by rule into a fixed device identifier and a variable production identifier. FDA's public device database keeps only the first — the fact capable of naming which specific unit shipped was never asked to be part of the record.
Detention doesn't need a warning letter
FDA's device import alerts authorize border detention from a documented inspection finding alone, no warning letter has to exist before or after. The list that runs on is a set of static web pages with no API behind them at all.
A Class I device, a Class I recall
FDA assigns a device its regulatory class once, as a permanent attribute of the device type. FDA assigns a recall its class per event, as a snapshot of one defect's severity. Both scales use the identical three labels, and a device's own class predicts nothing about the class of a recall against it.
21 CFR 820 didn't move. Its contents did.
FDA's Quality Management System Regulation, effective February 2, 2026, left the address unchanged and emptied most of what used to live there. A citation to Part 820 written last year and one written this year can point at the identical number and mean two different things.
The product code that doesn't exist yet
FDA's classification database has no row for a device type until a De Novo request is granted — the product code, the regulation number, even the classification itself are created by the grant order, not looked up before it. A watch keyed to "your product code" cannot fire on a category that is still being invented.
The classification posts. The 483 behind it doesn't.
FDA scores every closed device inspection No Action, Voluntary Action, or Official Action Indicated — a free, weekly, non-FOIA database. The Form 483 narrative behind that score is a different document, gated behind a records request FDA answers on its own schedule. A firm watch that conflates the two is missing the earlier, public half of the signal.
A recall has three dates, and the pipeline had to pick one
A device recall record carries three separate date fields — when the firm told the public, when FDA finished judging the hazard, and when the report posted — and they can be months apart. Read the wrong one as "when this happened" and a portfolio timeline is quietly off by however long the classification took.
The count is real. The rate is not.
A MAUDE search returns a number that looks like a fact you can compare — this many adverse event reports, this device, this window. FDA's own documentation says that number cannot become a rate, because nothing in the reporting system tells you how often the device was used.
The firm on the record is not the firm on the box
A device label is allowed by rule to carry a brand's name while a different company actually made the thing. FDA's enforcement records follow the maker, not the brand — so a firm watch keyed only to your own name has a blind spot built into it by design.
Low confidence is an instruction, not a hedge
Our classifier can say it doesn't know. That single field changes what happens to an item next — and it's a habit worth borrowing the day you're reading a draft this product, or anyone else's AI, handed you.
The same company, spelled three ways
FDA's own filings can't agree on how to spell a firm's name — a comma here, no comma there, Inc. versus INC. FDA Radar's matcher corrects for that, then stops on purpose, because the one join in this product that names a company is the one it refuses to make clever.
A device that was never a medical device
FDA published a Federal Register notice with the word Device, capitalized, in its own title. It has nothing to do with CDRH. Word-boundary matching fixes accidental substrings — it does nothing for a real word doing its ordinary job in the wrong industry.
FDA's warning letters, addressed by column number
The data behind fda.gov's warning-letter search has no field names — company, date, and subject are positions in an array, and nothing FDA publishes promises they'll stay in order. What a monitoring pipeline does about a contract nobody signed.
Your regulation has a decimal. FDA's watch doesn't.
A device classification regulation reads down to the section — 21 CFR 890.5740, powered heating pad. The Federal Register indexes rule changes only down to the part — 21 CFR 890. Watch at the wrong granularity and a real change to your regulation never matches.
Three letters is too short to search for
FDA Radar's own Federal Register filter once matched 'udi' inside 'studies' and nearly filed a drug guidance about antibodies as a device document. The failure mode behind it, and why the fix is a stricter filter, not a smarter one.
Most warning letters never close
FDA issues a close-out letter only after it has verified — usually by reinspection — that a firm's corrective actions actually worked. Violations that can't be corrected, and firms that no longer exist, get none. What the absence of one does and doesn't tell you.
The guidance that skipped the draft
FDA's Good Guidance Practices rule lets a significant guidance document skip the draft entirely — issued final, in effect, on the day it posts. The record's title doesn't tell you which path a document took to get there.
Ongoing, as of when?
openFDA's recall status field reads like a live indicator — Ongoing, Completed, Terminated. FDA's own documentation says it isn't one. What gets corrected on a recall record after it posts, what doesn't, and the practice for telling the difference.
The least interesting fact in a 510(k)
Cleared or not is a one-bit answer. The record underneath encodes the pathway, the conditions, and a disclosure choice the applicant locked in before submitting — and those are the fields worth reading across a product code.
No recall arrives with a product code attached
openFDA's recall data has a field for it. Across the last 300 device recalls we ingested, that field came back empty every time. The practice for finding your portfolio in a feed that isn't indexed by the thing you'd search for.
The deadline that doesn't email you
A Federal Register comment period can run ten days or nine months, and nothing on the page warns you which. The field that has the real answer, and the habit that checks it every week.
The warning letter has two dates
One starts your compliance clock. The other is what the public sees, and it can lag by weeks. Confuse them and the subject line's real signal goes unread too.
How to monitor FDA without drowning
Four official sources cover the material risk to a device portfolio. The hard part is not finding them — it is surviving their volume.
Your predicate was recalled. Now what?
A recall on the device your clearance compares against is not automatically your problem — and is never automatically not your problem. The assessment that tells you which.
Why no item reaches you without a human
The model drafts. It is structurally unable to publish. The enforced rule that makes our review a fact rather than a promise — and why this audience should demand one.
The posts explain the method. The product runs it.
Enter your products once; FDA Radar watches the same four sources daily and joins every item against your portfolio — reviewed by a person before it reaches you.