The pilot that needed a statute

Almost every mechanism this blog has traced — a 510(k), a PMA, a De Novo, a PCCP — answers a question about one device at a time. In 2017 FDA opened a pilot built on a different question entirely: instead of reviewing the device, what if the agency reviewed the company that made it, once, and let that review stand in for part of what premarket submissions are for?

Appraise the maker, not the device

The Digital Health Software Precertification (Pre-Cert) Pilot Program selected nine participants — from Apple and Samsung to smaller digital-health firms — out of more than a hundred applicants, to test a Total Product Life Cycle approach built around organizational excellence rather than a single submission. The premise: a firm with a demonstrated culture of quality and a real commitment to monitoring its software once it shipped could earn a streamlined path to market for future products, with less premarket evidence required up front because the organization itself, not just the device, had already been vetted.

The report that ended it

FDA closed the pilot with its own account of what it learned, in a September 2022 report on the five years of work. The finding was not that the idea failed on the merits. It was that building it out for real — a working, operational precertification program, not a pilot — would need a legislative change. FDA does not have standing statutory authority to certify a company instead of a device and let that certification carry legal weight in a marketing decision. Five years of pilot work ended at the edge of what Congress had actually authorized, not at the edge of what the agency had learned how to do.

The report is not shy about the reason it stopped. The idea could work. It could not be built out of authority the agency already had.

What got a statute instead

Three months after that report, in December 2022, Congress added Section 515C of the FD&C Act — the Predetermined Change Control Plan. It authorizes something that sounds adjacent to Pre-Cert’s premise: pre-authorized future changes without a new submission each time. But it is scoped the opposite way. A PCCP lives inside one device’s own 510(k), De Novo, or PMA — a plan FDA agrees to for that clearance, naming what will change and how it will be verified. It never certifies a company for its next product the way Pre-Cert proposed to. The device-by-device scope is exactly what let Congress write it into law: a change to one file’s own terms is a narrower thing to authorize than a standing judgment about a firm.

The method

A pilot and a statute can describe strategies that sound alike from a press release and carry entirely different weight in practice. A guidance document, an enforcement- discretion policy, or a pilot program is FDA acting on authority it already has, and FDA can narrow, pause, or end it on its own schedule — which is exactly what happened here. A provision written into the FD&C Act needs an act of Congress to undo. Reading which kind of authority stands behind an FDA initiative, before treating its existence as durable, is a habit worth keeping for any program that sounds like it might reshape how a device reaches market. This describes how two mechanisms were built, never a recommendation about what either means for a specific filing.

No public FDA database ever carried a field for Pre-Cert participation as a device attribute, and none needs to now — the program that would have populated it closed in 2022. See what we monitor and how often for the mechanisms that do reach a public record today.