The count Congress had to legislate

FDA Radar reads four sources: Federal Register notices, warning letters, device recalls, 510(k) clearances. A fifth kind of document sits entirely outside that list — not hidden, not undisclosed, published openly on FDA’s own site — and until recently, FDA itself had no structured public count of how many it issues in a given year either.

A safety communication needs no recall behind it

21 U.S.C. § 375(b) (Section 705(b) of the FD&C Act) gives FDA broad authority to disseminate information about a device that presents an imminent hazard to health — authority that has nothing to do with the recall machinery in 21 CFR Part 806, which runs on a firm’s own violation and its own ten-working-day reporting clock. A Medical Device Safety Communication is FDA’s document, not the manufacturer’s, and it doesn’t require a recall to exist at all: of the 51 device safety-related communications FDA issued between January 2023 and December 2024, only six were framed around a recall that had already resolved the problem. The rest were new safety information or updates to an earlier communication, with no recall number attached to any of them.

No trigger, no deadline, no database

No regulation sets a threshold that forces FDA to issue a safety communication, and none sets a deadline for a firm to act once one is published — it is an information tool, not an enforcement order. It is also the one FDA device document type with no home in openFDA: the device API publishes seven endpoints — 510(k) clearances, classification, PMA, recalls, adverse events, registrations, UDI records — and a safety communication is not among them. It exists only as an HTML page on fda.gov’s own year-by-year listing, read one at a time, by whoever remembers to look.

A document FDA writes, publishes, and stands behind can still be something no database in the government returns a single row for.

The count Congress had to legislate

That absence is why the Consolidated Appropriations Act, 2023 (Public Law 117-328) had to order one into existence. The statute directs FDA to report, not later than September 30, 2023 and biennially thereafter, on the number of postmarket device safety communications it issued, the data sources behind them, and how each was resolved — and to publish that report on FDA’s own website. The report covering January 2023 through December 2024 is, as of this post, the only structured public accounting of these documents that exists anywhere: 51 total, 27 of them CDRH Safety Communications, 23 Letters to Health Care Providers, one from CBER. Not a feed. Not a query. A PDF, filed every two years because a statute now requires it.

The practice

None of FDA Radar’s four sources will ever surface a safety communication, and neither will any other structured feed — the only way to see one as it publishes is to check fda.gov’s own listing directly, for a device category you watch, alongside what FDA Radar monitors and what it doesn’t. Finding one there says nothing about whether a recall exists behind it; the two records live in different systems, on different triggers, and have to be checked separately. This is regulatory intelligence about where the document lives and how thin its public record is, never regulatory advice about how to respond to one.