FDA may recognize all, part, or none of a standard established by a national or international SDO.
Recognition is the process whereby FDA identifies standards to which manufacturers of medical devices may submit a Declaration of Conformity to demonstrate they have met relevant requirements in the FD&C Act.
In general, the FDA actively assesses the impact of new consensus standards and revisions of existing standards on the premarket review process and recognizes these standards, as appropriate. As FDA determines that new or revised standards are appropriate for meeting requirements under the FD&C Act for medical devices, the agency updates the standards database on their website, which can be found at: FDA Recognized Standards. Once the agency has decided to recognize a standard, it issues a recognition number and provide supplemental information in the database. Any interested party may submit a request for recognition. To recognize such standards, the agency periodically publishes a recognition list in the Federal Register. FDA usually performs the activity at least twice annually. Superseded standards that the FDA has withdrawn from the list of recognized standards cannot be used in a Declaration of Conformity.