The U.S. Food and Drug Administration (FDA) has issued a guidance on how the agency addresses requests for recognition of a voluntary consensus standard for use in the assessment of medical devices.
Issued in mid-September, the guidance, “Recognition and Withdrawal of Voluntary Consensus Standards,” details the procedures the agency’s Center for Device and Radiological Health (CDRH) follows in evaluating potential consensus standards and sets forth the principles it uses to recognize a standard wholly, partially or not at all. The guidance also provides information on the reasons or rationale behind decisions to withdraw a consensus standard.
Voluntary consensus standards that have been “recognized” by the FDA have been evaluated and determined as appropriate for use by medical device manufacturers in demonstrating conformity with the FDA’s relevant requirements. Frequently, consensus standards recognized by the FDA can also be used to demonstrate conformity with requirements in other jurisdictions, such as the European Union’s Medical Device Regulation (MRD).
Read the full text of the FDA’s guidance on voluntary consensus standards.
