FDA Streamlines Process for Accepting Consensus Standards

We are seeing the impact of the 21^st 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 has removed from the FDA-recognized standard list, then compliance to the recognized version of the standard will be required.

How Does CDRH Use Consensus Standards

Conformance with recognized consensus standards can support CDRH’s assurance that various aspects of a medical device are safe and effective. When submitting a 510(k), conformance to recognized consensus standards often helps establish substantial equivalence of a device to its predicate, particularly if the predicate device complies with the same consensus standard. Additionally, if a submission includes a declaration of conformity to recognized consensus standards, then CDRH’s need to review the actual test data that relates to those standards may not be necessary. Conformity to these standards often simplifies and streamlines the review process, and can minimize the amount of data needed to demonstrate substantial equivalence.

How to Submit a Request for Recognition of a Medical Device Standard

Any medical device manufacturer or interested party can submit a request to the FDA for recognition of a consensus standard. To submit a request for recognition, the following information should be included:

• Name and address of the contact and organization
• Title, reference number and date of the standard
• Proposed list of devices that would be included under the standard’s declaration of conformity
• Scientific, technical, regulatory, or other basis for the request
• Identification of testing, performance or device characteristics that would be addressed by a declaration of conformity.

Requests can be submitted to the CDRH Standards Program by mail or electronically via email.

Under the revision of this policy, FDA’s CDRH (Center for Devices and Radiological Health) will respond to requests within 60 days. The response will provide FDA’s rationale for recognition of all, part or none of the standard being reviewed, as well as any scientific, regulatory or technical issues that impacted their decision. The decision will be published online in the US Federal Register.

More information about consensus standards can be found in FDA’s Guidance for Industry and FDA Staff – Recognition and Use of Consensus Standards and Frequently Asked Questions on Recognition of Consensus Standards.

Other US FDA Resources from MethodSense:

• Support for US FDA Clearance for Medical Devices
• Safety Testing and Essential Performance to IEC 60601-1
• FDA 510(k) Submission Action List

Photo Credit: Sebastien Wiertz