- Companies seeking to appeal internal supervisory review of significant decisions made by FDA's device center now can look to a rule finalized by the agency Tuesday for guidance on how to do just that. The new regulations also implement procedural requirements for other types of supervisory review for Center for Devices and Radiological Health decisions.
- FDA largely ignored comments on the proposed rule from AdvaMed such as a request to consider a grant or decline of a Clinical Laboratory Improvement Amendments waiver or De Novo classification request as a significant decision.
- FDA estimated the regulations will not be a major change, saying "the costs and benefits of the final rule will be negligible."
FDA said companies should try to resolve disputes with CDRH before a formal regulatory decision is made, and companies can use the device center's ombudsman to help mediate any dispute.
"The general expectation is that the stakeholder will follow an orderly progression of interaction with Center employees followed by outreach to relevant members of management and then engagement with the CDRH Ombudsman, prior to filing a formal request for review," FDA wrote in a statement. "However, a stakeholder may file a request for review at any time that is permissible under applicable statutory and regulatory provisions."
AdvaMed, which submitted the only substantive comment on the proposed rule, praised the appeal process as a "fundamental mechanism" to understand FDA's decision-making.
Under the final rule, companies have 30 days after a CDRH decision to appeal for supervisory review. FDA then has 30 days to schedule an in-person meeting or teleconference review if it is requested. After an in-person meeting, FDA is required to make a decision within 30 days. For teleconference reviews, it must issue a decision within 45 days.
The 21st Century Cures Act, signed into law in 2016, added a requirement FDA document least burdensome considerations in its summaries explaining significant decisions.
Companies can ask for internal review of a significant decision — also known as a 517A decision — for certain actions related to a 510(k) submission, Premarket Approval Application, Humanitarian Device Exemption application, breakthrough device designation request or investigational device exemption application.
FDA also outlines time requirements for non-517A decisions: companies must appeal for review within 60 days of a decision or else "these cases will be denied as untimely." AdvaMed requested the timeline be extended to 90 days for non-517A decisions, but the request was rejected.
An AdvaMed request for additional time to request supervisory review after a company receives details of a CDRH 517A decision was also declined by FDA in the final rule.
"While the substantive summary may include additional information, such as documentation of significant controversies or differences of opinion and the resolution of such, if applicable, that additional information is not necessary to file an appeal," FDA states.
The final rule goes into effect on Aug. 1, 2019.