Search FDA Recognized Consensus Standards
Search FDA's Recognized Consensus Standards for medical devices: every standard FDA currently recognizes, so a premarket submission can declare conformity to it. Find recognitions by designation (e.g. "ISO 10993-1", "IEC 60601-1-2"), by device product code (the standards FDA lists for that device type), or by words in the title and scope; keep complete or partial recognitions only with extent. Each result gives the recognition number, extent, status (current, or superseded with the date declarations to it stop being accepted) and product codes. FDA lists product codes as examples, so a standard missing for a code may still apply. Call read_fda_standard for the full sheet: the parts a partial recognition excludes, transition, scope, rationale and related guidance.
Request
- Base URLhttps://api.assyro.com
- Authnone declared
Query parameters
Words in the standard's title, scope or device names, e.g. "sterilization validation".
A standard designation, with or without the organization, e.g. "ISO 14971" or "ASTM F2554".
An FDA device product code, e.g. "OLO".
Only complete or only partial recognitions.
Recognitions to return, default 8.
Skip this many results (for paging), default 0.
Response
Matching records.
Changes
No recorded changes to this operation across all 1 revision of this API.