Jul 2, 2019

A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed.

The final rule follows draft guidance in late 2017 as well as a proposed rule  in early 2018, adding additional procedures for how US medical device premarket applicants may appeal some CDRH regulatory decisions. Implementation of these procedures, expected in August 2019, were stipulated by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the 21st Century Cures Act of 2016.

FDA argues that the final rule provides more transparency for both medical device market applicants and CDRH staff in terms of how supervisory reviews of decisions should be handled, as well as a more predictable process and clear deadlines for agency responses to appeals.

Major components of the CDRH appeals process

The final rule stems from Section 517A of the US Food, Drug & Cosmetic Act, which allows any person or party to request supervisory review of any significant decision made by CDRH. The rule is applicable to what FDA has termed “517A decisions,” defined as significant decisions made by CDRH according to Section 517A.

The types of CDRH decisions qualifying as 517A decisions and thus subject to appeal pertain to premarket submissions or reviews for the following subjects:

  • 510(k): Not substantially equivalent; Substantially equivalent
  • Premarket Approval (PMA) or Humanitarian Device Exemption (HDE): Not approvable; Approvable; Approval; Denial
  • Breakthrough Device Designation Request: Grant; Denial of request for breakthrough designation
  • Investigational Device Exemption (IDE): Disapproval; Approval
  • Failures to Reach Agreement on a protocol under FD&C Act Section 520(g)(7)
  • Clinical Hold decisions according to FD&C Act Section 520(g)(8)

Interested parties may also request reviews of CDRH decisions that do not fall under the 517A purview; however, such requests must be received by the Center within 60 days of the date of the decision in question.

Requests for review of both 517A and non-517A decisions are addressed by the next-highest organizational level or supervisory rank from the department or individual issuing the decision under appeal, and should be accompanied by rationales for elevated review.

Learn more about US FDA medical device regulations at Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA Pre-Sub (Q-Sub) consulting for medical device companies
  • Whitepaper: Early communication with the FDA