The FDA's Center for Devices and Radiological Health provided clarification on how it will process requests for recognition of voluntary consensus standards for medical devices under the 21st Century Cures Act. The process will include a 60-day deadline for the FDA to respond to requests in written form and publication of the agency's rationale for nonrecognition or recognition of all or part of a standard in the Federal Register.
CDRH unveils changes to process for consensus standard recognition requests
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