Voluntary consensus standards guidance updated by FDA
The US Food and Drug Administration has issued a final guidance addressing voluntary consensus standards, updating a September 2018 version.
The final guidance also supersedes one issued in 2007 by the Center for Devices and Radiological Health (CDRH) entitled “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition.”
The final document, issued jointly by CDRH and the Center for Biologics Evaluation and Research (CBER), lays out the procedures used by CDRH when the office receives requests for recognition of voluntary consensus standards for medical products.
Options for agency actions in this case include complete or partial recognition, or non-recognition. The agency may also withdraw standards from recognition…