Exempt from registration. Not from 510(k).

A physician who builds or alters a device solely for their own patients, in their own practice, reads 21 CFR 807.65(d) and finds the word they were looking for: exempt. It is easy to stop reading there. The exemption that paragraph grants is real, and it is also narrower than the word suggests, because it answers one question FDA asks of a device, not all of them.

What Section 510(g) actually covers

Section 510 of the FD&C Act is titled, in full, “Registration of producers of drugs or devices,” and Section 510(g), at 21 U.S.C. § 360(g), carves out the classes of persons who don’t have to do that registering. FDA’s implementing regulation, 21 CFR 807.65, lists them one at a time: raw-material suppliers, pharmacies and retail outlets, and, at paragraph (d), “licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.” FDA’s own device registration guidance spells out the boundary in practice: the exemption covers a device built for the practitioner’s own patients, and it stops the moment that practitioner starts distributing the same device to other practitioners.

The exemption has its own geographic limit too: the regulation’s lead-in restricts paragraphs (d), (e), (f), and (i) to persons located in a State as the Act defines that term, so a licensed practitioner operating entirely outside the United States and its territories doesn’t get it.

A different letter, a different duty

Section 510(k), 21 U.S.C. § 360(k), sits inside the same section of the same statute, under the same title about registration. It has nothing to do with registering an establishment. It is the premarket notification duty: before introducing a device into interstate commerce, the person responsible has to notify FDA and, ordinarily, clear the review FDA runs in response. Nothing in 807.65(d)’s text, and nothing in 510(g) itself, touches that duty at all. An exemption written into one letter of Section 510 does not travel to a different letter of the same section just because the two letters share a number.

A practitioner exempt under 510(g) has answered whether they have to register. Whether the device they built needed a 510(k) is a question 510(g) was never asked.

Where an actual exemption from review has to come from

If a practitioner-made device is also going to skip premarket notification, that exemption has to come from somewhere that actually reaches 510(k) — most commonly the custom device exemption at FD&C Act § 520(b), defined at 21 CFR 812.3(b): a device that necessarily deviates from a generally available one to meet an individual patient’s named order, capped at five units of that device type a year, with its own annual notice to FDA. That exemption is specific, conditional, and unrelated to whether the practitioner also registers an establishment. A device can fail every condition of 812.3(b) and still have been made by a practitioner who is, correctly, exempt from registering under 807.65(d) — and owe FDA a 510(k) regardless.

The practice

Reading “exempt” next to a citation is not the same as reading which duty the citation exempts. 807.65(d) answers a registration question; it was never written to answer a premarket-review question, and nothing about one exemption’s existence implies the other. Whether a specific device actually needs a 510(k), a PMA, or qualifies for its own separate exemption is a determination for the regulatory professionals who own that device — this describes how the statute is built, regulatory intelligence and method, never advice about a specific device.

It also describes a blind spot built into any record search. Per what we monitor and how often, FDA Radar’s five feeds start from events that generate a public record: a clearance, a classification, a letter, a recall. A device made under 807.65(d) alone, with no 510(k) filed because none was thought to be owed, leaves nothing in any of them to find; a device that filed the 510(k) its maker actually needed shows up exactly where it should. The two devices can come from the same kind of practitioner, and only one of them is missing from the record for a reason the record itself will never flag.