FDA Recognized Consensus Standards

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 Each result gives the recognition number, extent, status (current, or superseded with the date declarations to it stop being accepted) and product codes.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.

get/v1/sources/fda-standards/search

Request

  • Base URL
    https://api.assyro.com
  • Auth
    none declared

Query parameters

querystring

Words in the standard's title, scope or device names, e.g. "sterilization validation".

designationstring

A standard designation, with or without the organization, e.g. "ISO 14971" or "ASTM F2554".

productCodestring

An FDA device product code, e.g. "OLO".

extent'complete' | 'partial'

Only complete or only partial recognitions.

limitinteger

Recognitions to return, default 8.

offsetinteger

Skip this many results (for paging), default 0.

Response

Matching records.

versionunknown required
totalinteger nullable required

Total matches the source reports, when it says.

notestring
summarystring[]

Changes

No recorded changes to this operation across all 1 revision of this API.