FDA Recognized Consensus Standards for Medical Devices

Begin with the device, intended use and characteristic that requires evidence. A standard may address terminology, a test method, a performance characteristic or a broader system. Its relevance depends on the device and submission. Recognition does not establish that every part of the standard applies to every device within a broad commercial category.

FDA’s database identifies recognized standards and associated information. Examine the designation, edition, recognition number and any supplemental information. Complete and partial recognition have different implications. Review exclusions, limitations and transition information in the actual record rather than treating the presence of a standard’s title in a search result as unrestricted recognition of all provisions.

Consensus standards are generally used voluntarily in this context. A separate regulation can incorporate a standard or establish a mandatory performance requirement. Those obligations must be assessed through the adopting provision. QMSR incorporation of ISO 13485:2016, for example, should not be confused with the general voluntary recognition pathway for standards supporting a device submission.

Where the submission uses a declaration of conformity, examine FDA’s conditions for that use and the recognized scope. NCQM practice consideration: connect the claimed provisions to the test reports, analyses and device configuration. Identify deviations and provisions not addressed. A laboratory report to a standard does not by itself explain the scope of a manufacturer’s declaration.

A publisher’s new edition does not automatically replace the edition FDA recognizes. Check the current recognition record and any transition or withdrawal conditions. Internally, retain the edition used for testing and assess changes in methods, criteria or scope. A report to an older edition may contain useful data without supporting an unrestricted statement of conformity to a newer one.

Recognition of a standard is not FDA certification of a laboratory, manufacturer or product. It also does not replace the applicable submission pathway, labeling, quality system or postmarket duties. Use the recognition record with the device’s requirement register and submission strategy, then retain the basis for the technical conclusion and the source-check date.