CDRH Clarifies Process for Consensus Standard Recognition Requests

Regulatory News

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new 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 FDA allows device makers to submit a declaration of conformity to show that their device is in line with a specific standard.

FDA currently recognizes more than 1,200 consensus standards for medical devices developed by standards bodies such as the International Organization for Standardization (ISO), American National Standards Institute (ANSI) and the International Electrotechnical Commission (IEC).

Under the Cures act, FDA is directed to respond to such requests in writing within 60 days of receiving the request. The agency is also required to publish its rationale for recognizing all or part of the standard, or for not accepting it, in the Federal Register.

For those looking to get a new standard recognized by the agency, FDA asks that they send a request including the name of the standard, its reference number and a list of devices that the standard should routinely apply to for declarations of conformity.

To back up the request, FDA says they should include a scientific, technical and regulatory rationale for the standard, as well as "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.

FDA