CDRH Clarifies Process for Consensus Standards Recognition Requests

The FDA’s Center for Devices and Radiological Health (CDRH) has provided clarification on how it will process requests for the recognition of voluntary consensus standards for medical devices, as required by the 21st Century Cures Act. Medical device makers often rely on consensus standards in the development and testing of their products and the FDA allows device makers to submit a declaration of conformity to show that their device is in line with a specific standard.

The 21st Century Cures Act of 2016 modified Section 514(c) of the Federal Food, Drug, and Cosmetic Act. Any interested party may submit a request for recognition of an appropriate standard established by a nationally or internationally recognized standard organization. The process includes a 60-day deadline for the FDA to respond to requests in written form and publication of the agency’s rationale on its website for nonrecognition or recognition of all or part of a standard in the Federal Register.

The FDA states that, “a request for recognition of a standard should contain, at a minimum, the following information:

  • Name and electronic or mailing address of the requestor,
  • Title of the standard,
  • Any reference number and date,
  • Proposed list of devices for which a declaration of conformity should routinely apply,
  • Basis for supporting such recognition request, e.g., including the scientific, technical, regulatory, or other basis for such request, etc., and,
  • A brief identification of the testing or performance or other characteristics of the device(s) or process(es) that would be addressed by a declaration of conformity.”

In light of the new policy, FDA says it is also considering updates to three of its existing guidance documents related to consensus standards, including Recognition and Use of Consensus Standards, CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition, and Frequently Asked Questions on Recognition of Consensus Standards.