Consensus Standards Lookup

What "recognized" means, and what it does not

Under section 514(c) of the Food, Drug, and Cosmetic Act, FDA recognises all or part of standards developed by standards organisations. Recognition means one specific thing: a manufacturer may submit a Declaration of Conformity to that standard to help meet a premarket submission requirement. It does not mean the standard is required, and it does not mean the standard applies to any particular device.

The statute is explicit that a submitter may instead "use data, or information, other than data required by a standard recognized." A standard becomes mandatory only where a regulation incorporates it by reference. And FDA may decline a Declaration of Conformity where it finds the standard is not applicable to the device under review — which is precisely why a tool cannot tell you what applies to yours.

Why so many searches come back empty

FDA's recognition records sometimes name product codes, as examples of devices the standard has been used for. Those lists are not a map of every device a standard touches, and for whole categories of standard there is no list at all: a standard on biological evaluation, or sterilisation, or electromagnetic compatibility, or software lifecycle, or risk management applies across device types and FDA maps it to none of them.

Measured over this snapshot: 668 of 1,740 recognitions carry no product code, and 1,630 of FDA's 7,088 product codes have any standard mapped. So a product-code search is a useful starting point and a poor stopping point, and this tool says so where the empty result appears rather than in a footnote.

Extent of recognition, and why it is on every row

"All or part of" is the statute's own language, and FDA acts on it: 154 of the 1,740 recognitions in this snapshot are partial, meaning FDA recognised the standard except for clauses it names. ISO 10993-1, the biological-evaluation standard almost every device programme touches, is one of them.

A list that showed "ISO 10993-1 — recognized" without the excluded clauses would be a false statement about the public record. So the exclusions travel with the record: on the row, in the print view, and in every exported CSV.

Where this data comes from

FDA's Recognized Consensus Standards database, retrieved 2026-09-01, corresponding to Federal Register Recognition List Number 066. There is no API for it — openFDA has no standards endpoint, and FDA's own data catalog lists a single distribution for this dataset: an interactive HTML database. So this is a dated snapshot, harvested politely, and the date is on every view.

FDA updates that database before announcing changes in the Federal Register, which means the live database can be ahead of any snapshot, including this one. Where they differ, FDA's database governs, and every record here links to its FDA page so you can check it in one click.

Why we are giving it away

Because it is public data behind a database that cannot be queried in bulk, and assembling a citable shortlist by hand is an afternoon nobody should spend twice. The discipline that shows up here — every figure carries its source and its date, and the tool refuses to make a judgement that belongs to a regulatory professional — is the same discipline in the DHF gap reports we charge for.

Questions we get

Does this tell me which standards apply to my device?

No, and it is built not to. FDA recognises standards; whether one applies to a particular device is the submitter’s judgement, and FDA can decline a Declaration of Conformity where it finds a standard is not applicable to the device under review. This tool shows the public record and lets you build your own shortlist from it.

I searched my product code and got nothing. Does my device need no standards?

No — that inference is exactly what the empty result is designed to prevent. FDA lists product codes on a recognition as examples rather than as a complete map. In this snapshot 668 of 1,740 recognitions name no product code at all, and only 1,630 of FDA’s 7,088 product codes have any standard mapped to them. Biocompatibility, sterility, EMC, software and risk-management standards are mapped to no device type whatsoever.

What does "Partial" mean next to a standard?

That FDA recognised part of the standard and named the clauses it did not. "All or part of" is statutory language — FD&C Act §514(c)(1)(A). A partial recognition shown without its excluded clauses would misstate the record, so this tool shows them on the row and in every export. 154 of 1,740 recognitions here are partial.

Does recognition mean the standard is required?

No. Recognition means a manufacturer may submit a Declaration of Conformity to it. The statute expressly preserves the right to use other data or information instead. A standard is only required where a regulation incorporates it by reference.

Why is the data a snapshot rather than live?

Because there is no API. openFDA has no standards endpoint, FDA publishes this dataset only as an on-screen HTML database, and that database rate-limits aggressively. A live browser-side lookup is not buildable against it, so this ships a dated snapshot and tells you its date.

How current is it?

This snapshot was retrieved 2026-09-01 and corresponds to FR Recognition List Number 066. FDA updates its database before publishing changes in the Federal Register, so the live database can be ahead of any snapshot including this one. Where they differ, FDA’s database governs.