A recall closes. A radiation refund doesn't.

A diagnostic imaging system throws a dose-calibration fault, or a surgical laser ships with a defect in its exposure control. The firm traces the cause, files a correction under 21 CFR 806.10, reports it to FDA within the ten working days the rule allows, and notifies the users who already have one. The device file reads closed. A second federal statute, running on its own trigger and its own remedy, may not be finished at all.

What triggers Part 1003, independent of Part 806

The Electronic Product Radiation Control provisions of the FD&C Act — 21 U.S.C. § 360ll — require a manufacturer that discovers a “defect”, as 21 CFR 1003.2 defines it, or a failure to meet a performance standard issued under 21 U.S.C. § 360kk, to notify FDA and its own dealers and distributors under 21 CFR 1003.10. The defect definition runs on two branches: a product that doesn’t use radiation for its purpose, whose emissions create a risk of injury or miss the product’s own design specification, or a product that does use radiation for its purpose, whose emissions fall outside that specification or exceed what the purpose needs. Neither branch asks whether the issue “presents a risk to health” the way 806.10 does — that is a device-correction test, not a radiation-defect test, and a firm can satisfy one without ever touching the other. If FDA finds the defect itself, through testing, inspection, or its own review of reports, 21 CFR 1003.11 lets the agency notify the manufacturer of that determination directly, without waiting on a self-report that may never come.

The remedy Part 806 never asks for

21 CFR 806.10 and Part 803’s malfunction reporting both end at the same place: FDA gets told. Neither requires the firm to make anyone whole. 21 CFR Part 1004 does. Once a defect or standard failure under Part 1003 stands — and isn’t exempted under 21 CFR 1003.30, which puts the burden of proving no significant risk of injury on the manufacturer — 21 CFR 1004.1 requires the firm to do one of three things, at its own cost: correct the product so it meets the standard, replace it with a conforming unit, or refund the purchase price. A device correction report and an MDR are both disclosures. A Part 1004 plan is a bill.

A device correction tells FDA what happened. A Part 1004 plan tells FDA how the manufacturer is going to pay for it.

Where the record actually lives

The notice and the corrective-action plan that follow don’t run through the same public channel as a device recall. FDA keeps them in a separate system — Radiation-Emitting Electronic Products Corrective Actions — searchable by manufacturer, product, performance standard, and date, apart from the openFDA enforcement data behind every device-recall record this blog reads. Per what we monitor and how often, FDA Radar’s four continuously monitored feeds are the Federal Register, FDA warning letters, device recalls and enforcement, and 510(k) clearances. A radiation-specific corrective-action plan isn’t carried in any of them — not because it’s confidential, the way a Part 1002 product report’s accession number is, but because it sits in a public system built for a different statute, one almost nobody checks once a device-correction notice already looks like the whole story.

The practice

A device correction closed under 806.10, and an MDR filed under Part 803, answer the device question FDA asked. Neither one answers whether the same unit’s radiation performance tripped Part 1003’s own defect definition, and neither one satisfies Part 1004’s remedy if it did. This is regulatory intelligence and method, never regulatory advice about whether a specific defect meets Part 1003’s definition, or what a specific corrective-action plan under Part 1004 has to offer — those are determinations for your regulatory professional, built on the current text of both parts, not on whatever the device-correction record already says.