Regulatory
FDA Recognized Consensus Standards
In one line
Voluntary standards that FDA has formally recognized for use in establishing device conformity.
Definition
FDA's Recognized Consensus Standards database lists ISO, IEC, ASTM, AAMI, and other standards that sponsors can declare conformity to via a Standards Data Report, simplifying review of the corresponding submission elements.
The database shows the extent of recognition for each standard, and FDA may recognize only some clauses. Recognition does not make a standard mandatory, and citing a superseded or withdrawn version can raise review questions.
Why it matters
Choosing recognized standards (and citing the recognition number) is the cleanest way to streamline 510(k) and De Novo reviews.
Common pitfalls
- •Manufacturers sometimes assume that demonstrating conformity to a recognized standard automatically guarantees market clearance, which is not always the case, as the FDA still performs a comprehensive review.
- •A common pitfall is failing to cite the specific recognition number of the standard in regulatory submissions, which can lead to delays as reviewers must independently verify the standard's status.
- •Over-reliance on recognized standards without thoroughly understanding their applicability to a specific device can result in inadequate testing or documentation.
- •Confusing "recognized consensus standards" with general industry best practices can lead to submissions that do not meet FDA expectations.
- •Ignoring updates to recognized standards or the FDA's recognition status can lead to submitting outdated information, requiring resubmission or additional data.
Sources
- FDA Standards Database · FDA
- RAPS Regulatory Focus · RAPS
- FDA - Medical Devices · FDA