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FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA for recognition of a standard that has been established by a nationally or internationally recognized standard organization. What Are Recognized Consensus Standards A recognized consensus standard is a national or international standard that FDA has evaluated and recognized for use in satisfying a regulatory requirement and for which FDA has published a notice in the Federal Register. Many consensus standards address aspects of safety and effectiveness that are relevant to medical devices. When a medical device manufacturer is submitting a premarket application, such as a 510(k), Investigation Device Exemptions application (IDE) or a Premarket Approval application (PMA), it must demonstrate to CDRH (Center for Devices and Radiological Health) that their device is safe and effective. Applicants may be able to demonstrate safety and effectiveness by conformance to FDA-recognized consensus standards. When planning performance and safety testing, manufacturers should review the list of FDA-recognized standards to determine if the standard they are considering is listed. FDA recommends that plans to conform to particular standards be discussed during pre-submission meetings. If testing has already been conducted to a standard not recognized by the FDA but acceptable in another market, a request for recognition will need to be submitted to FDA. If testing has already been conducted to a past version of a standard that the FDA...