FDA Recognized Consensus Standards
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 Recognition does not make a standard mandatory, and citing a superseded or withdrawn version can raise review questions.What this means in practice
Choosing recognized standards (and citing the recognition number) is the cleanest way to streamline 510(k) and De Novo reviews.Examples
- A manufacturer of a new infusion pump ensures its electromagnetic compatibility (EMC) testing follows IEC 60601-1-2, an FDA-recognized standard for medical electrical equipment, and cites the recognition number in their 510(k) submission.
- A software developer for a medical device incorporates cybersecurity controls compliant with IEC 80001-1, an FDA-recognized standard for risk management of IT networks in healthcare, to address cybersecurity concerns.
- A company developing a biological diagnostic test conducts performance validation according to an ASTM standard, which is recognized by the FDA for specific analytical methods, reducing the need for extensive raw data submission.
- •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- •Ignoring updates to recognized standards or the FDA's recognition status can lead to submitting outdated information, requiring resubmission or additional data.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
General requirements for basic safety and essential performance of medical electrical equipment.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA Standards DatabaseTier 2 VerifiedFDAaccessdata.fda.gov
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
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