The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH).
The proposed rule is in line with legislative requirements established by the Food and Drug Administration Safety and Innovation Act(FDASIA) and 21st Century Cures Act (Cures) for clarifying procedures and timeframes for appeals of "significant decisions" to CDRH.
Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), as added by FDASIA, establishes that FDA must provide "a substantive summary of the scientific and regulatory rationale for any significant decision" by CDRH and created timeframes for when those appeals must be submitted and when FDA must respond by.
FDA says the new rule will provide greater transparency to companies requesting supervisory review and set expectations for when the agency will act on such requests.
The proposed rule would also establish which decisions by CDRH qualify as "significant decisions" subject to appeals, and set up procedures for requesting supervisory review of other decisions not covered by FDASIA or Cures.
But Section 517A did not define what decisions are considered significant. Prior to issuing the proposed rule, FDA detailed its interpretation of what qualifies as a significant decision in its Section 517A questions and answers guidance, which was last updated in September 2017.
Now, FDA's proposed rule would codify what decisions fall under the scope of Section 517A, thought he agency says it will use the term "517A decisions" rather than "significant decisions."
Such decisions include:
- Not substantially equivalent
- Substantially equivalent
- Premarket Approval (PMA)/Humanitarian Device Exemption (HDE):
- Not approvable
- Breakthrough Devices:
- Denial of request for breakthrough designation
- Investigational Device Exemption (IDE):
- Failure to reach agreement on protocol under Section 520(g)(7) of the FD&C Act
- "Clinical Hold" determinations under section 520(g)(8) of the FD&C Act
FDA is also proposing to establish procedures and timeframes for appealing decisions by CDRH that fall outside those covered under Section 517A. Under the proposed rule, requests for supervisory review of non-517A decisions must be received no later than 60 days after the decision date.
The proposed rule would also dictate that appeals that seek to bypass two or more levels of review include a rationale for skipping multiple supervisory levels and that such determinations be made solely at CDRH's discretion, and that appeals may only be made to the center director level after first going through the supervisory chain below the director.
Additionally, the proposed rule would require that all requests for supervisory review be submitted electronically to FDA in accordance with the agency's eCopy guidance.
Federal Register Notice