EMERGO SUMMARY OF KEY POINTS:

• New FDA process for accepting medical device consensus standards 
• 60-day timeframe for FDA review and acceptance of new standards
• What should be included in requests for recognition of standards

US medical device regulators at the Food and Drug Administration have disclosed a new process for evaluating and accepting voluntary consensus standards.

The new policy, mandated by the 21^st Century Cures Act of 2016, establishes a 60-day deadline for the agency to respond to standard recognition requests submitted by recognized standard organizations. The FDA will furthermore respond to such requests in writing, and publish factors behind decisions to fully or partially accept, or reject, standards submitted for recognition by the regulator.

What to include in a request for recognition of a medical device standard

Standards organizations submitting requests for recognition to the FDA should include the following information, according to the agency:

• Organization’s name and address
• Title, reference number and date of the standard
• Proposed list of medical devices that would fall under the standard’s declaration of conformity
• Scientific, technical or other basis for supporting a request for recognition
• List of testing, performance and related device characteristics covered by declaration of conformity to the standard

Within 60 calendar days of receipt of a submission to the FDA’s Center for Devices and Radiological Health (CDRH) Standards Program, the agency will issue a determination on whether to accept all, part or none of the standard under consideration, and include any scientific, regulatory or technical issues affecting that determination. All determinations will also be published in the US Federal Register.

Request for recognition may be submitted electronically or via paper copy to the FDA’s Center for Devices and Radiological Health (CDRH).

The new standards recognition request process follows an FDA proposal earlier in 2017 to launch a pilot program, the Accredited Scheme for Conformity Assessment (ASCA), which would utilize testing laboratories to determine conformity assessments to voluntary consensus standards for medical devices.

Related US FDA resources and services from Emergo:

• US FDA consulting support for medical device and IVD companies
• Medical device design, process and validation services
• Whitepaper: Testing requirements for FDA 510(k) submissions