Built for drugs. Silent on devices.

A Regulatory Affairs team vetting a new device consultant, CRO, or contract manufacturer can reach for FDA’s debarment list the way it would reach for a sanctions screen — a name, a search, a clean or dirty result. The list is real, the search works, and for a device engagement it is checking the wrong thing.

A 1992 law built around one scandal

Section 306 of the FD&C Act, at 21 U.S.C. § 335a, came out of the Generic Drug Enforcement Act of 1992, signed into law after federal prosecutors found generic-drug manufacturers bribing FDA reviewers to move abbreviated new drug applications through approval on falsified data. Congress’s fix was blunt: anyone convicted of a felony for corrupting the development or approval of a drug application faces mandatory debarment under 306(a) — barred for good from submitting or assisting in any future drug application — and a broader, discretionary version under 306(b) reaches other federal felonies touching drug regulation, from bribery to false statements to obstructing an FDA investigation.

Three decades of device law never touched it

FDA’s own public list carries the scope in its title: the FDA Debarment List (Drug Product Applications). Every ground for debarment in Section 306 is written around a drug application — an ANDA, an NDA, a drug product submission — and nothing in the statute reaches a 510(k), a PMA, or a De Novo request. That gap wasn’t an early oversight later closed. FDAMA in 1997, MDUFMA in 2002, FDASIA in 2012, and the 21st Century Cures Act in 2016 all amended device law substantially, and none of them added a device-side debarment authority alongside it. The 1992 law solved a 1989 drug scandal, and Congress never generalized the fix.

The device-side sanction reaches a narrower target

The closest device-side mechanism, investigator disqualification under 21 CFR 812.119, is not a substitute. It bars a specific clinical investigator from running future studies under an IDE, for misconduct in a human-subject trial — a sanction aimed at a role in a clinical investigation, not at a person’s fitness to consult on, prepare, or submit a device application at all. A device consultant who has never run a clinical trial cannot appear on that list no matter what they did on a prior 510(k), because the list was never built to ask that question.

A clean search of FDA’s debarment list tells you a person hasn’t been barred from drug work. For a device engagement, that is the only thing it tells you.

The practice

A due-diligence check that stops at the debarment list is checking a real FDA record for a question the device side of the agency has no equivalent record to answer. What it can’t rule out — a felony conviction for fraud on a device submission, a debarment-equivalent finding that simply has nowhere to be listed — doesn’t show up as a gap in the search; it shows up as a clean result indistinguishable from an actual clean record. This is regulatory intelligence about what one public list does and doesn’t cover, never a substitute for whatever deeper screening a specific hire warrants, which is a judgment for the team doing the hiring.