Recognition and Withdrawal Process for Voluntary Consensus Standards
This guidance outlines FDA's procedures for reviewing and evaluating requests for standards recognition or withdrawal of recognition. It explains the regulatory framework, policies, and practices regarding FDA's recognition and withdrawal of voluntary consensus standards for medical devices.
What You Need to Know? 👇
What are the key requirements for FDA recognition of voluntary consensus standards?
Standards must be developed by organizations following OMB Circular A-119 principles: openness, balance, due process, appeals process, and consensus. They should demonstrate scientific merit and help meet FD&C Act requirements.
How long does FDA take to make a determination on standards recognition requests?
FDA must make a determination on recognition (complete, partial, or non-recognition) within 60 calendar days from the date the request was received, as mandated by statute.
Can FDA recognize international standards from organizations like ISO and IEC?
Yes, FDA prioritizes international and U.S. voluntary consensus standards for recognition. Standards from ISO, IEC, IEEE, and ASTM International typically meet FDA’s criteria for recognition.
What happens when a new version of an FDA-recognized standard is published?
FDA reviews the changes and decides whether to recognize the new version. If recognized, the older version is typically withdrawn, often with a transition period allowing use of both versions.
What information must be included in a standards recognition request?
Requests must include: requestor contact information, standard title and reference number, proposed product types for Declaration of Conformity, basis for recognition, and brief identification of testing/performance characteristics addressed.
Can FDA withdraw recognition of a previously recognized standard?
Yes, FDA may withdraw recognition if a standard is no longer appropriate for meeting device requirements under the FD&C Act, typically when superseded by new versions or deemed inappropriate.
What You Need to Do 👇
Recommended Actions
- Verify if the standard follows voluntary consensus development process with required attributes before requesting recognition
- Prepare complete recognition request package with all required information
- Contact Standards and Conformity Assessment Program before submitting request to confirm if FDA has access to the standard
- Monitor FDA Recognized Consensus Standards Database for updates on recognition status
- Plan for transition periods when standards are updated/withdrawn
- Consider both recognized and non-recognized versions during transition periods
- Document rationale for using non-recognized standards if needed
- Keep track of normative references within recognized standards
- Consider most recent FDA-recognized versions of normative references when applicable
- Maintain compliance with recognized standards used in submissions even after recognition withdrawal
Key Considerations
Other considerations
- Standards must be developed through a voluntary consensus process with the following attributes:
- Openness
- Balance
- Due Process
- Appeals Process
- Consensus
- Recognition requests must include:
- Requestor contact information
- Standard title, reference number and date
- Proposed product types for Declaration of Conformity
- Basis for recognition
- Brief identification of testing/performance characteristics addressed
- FDA can recognize standards:
- Completely
- Partially
- Not at all
- FDA must make determination within 60 days of request receipt
- Recognition can be withdrawn if:
- Standard is replaced by new version
- Standard is no longer appropriate for meeting requirements
Relevant Guidances 🔗
Related references and norms 📂
- OMB Circular A-119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities