CDRH appeals processes and provides guidance pertaining to FDA significant decisions.

The Center for Devices and Radiological Health (CDRH) issued an updated guidance document describing the processes available for individuals outside of the FDA to request a review of the decisions made by the CDRH on which they disagree with. Such processes that are recommended when an appeal for a decision is necessary includes requests for supervisory review, petitions, and hearings.

The processes and timelines for CFR 10.75 requests for appeal of “significant decisions” can be found in section 517A of the FD&C Act. Request for supervisory review for significant decisions are highlighted as decisions pertaining to 517A of the FD&C Act including 510(k)s, PMA/HDEs, breakthrough device designation requests, IDEs, failure to reach agreement on a protocol under section 520(g)(7) of the FD&C Act, and “Clinical Hold” determinations under section 520(g)(8) of the FD&C Act.

Requests for appeal of a 517A decision must be submitted no later than 30 days after the decision. For a non-517A appeal, FDA requires that requests for appeals be submitted within 60 days of the decision. A review meeting can be scheduled within the appeal for individuals to plead their case to the review authority. The submitter may also request that the review panel refer their dispute to an external team of experts like an Advisory Panel.

The format for requesting a supervisory review is also suggested in the guidance document. The request for the appeal should be clearly marked “APPEAL”, contain a summary of the issue in dispute, reasons an appeal is being sought and should include and reference the files pertaining to the decision. A decision for an individual requesting an appeal of a 517A decision should be made within 30 days of a meeting or within 45 days of a paper submission, if a meeting was not requested.

The Medical Devices Dispute Resolution Panel (DRP) provides advice on scientific disputes that individuals have with FDA decisions on PMA approvals and denials and other scientific matters, provided there is no other panel that has the right to review the dispute under the FD&C Act. To file a request, interested individuals must submit their request to the CDRH so the DRP can be included in the decision-making meeting. A request for review by the DRP should only be made once all other supervisory review options have been exhausted such as having the dispute reviewed by the relevant Office Director and Advisory Panel. The disputed issue should primarily be scientific in nature.

Petitions may be filed for PMA applications that have been denied under the FD&C Act within 30 days of the denial of the PMA. The most common types of petitions are the Citizen Petition and the Request for Administrative Reconsideration. A citizen petition may be submitted by any person to challenge an FDA decision or request an action from the FDA. A citizen petition should provide the FDA with information of the action requested and legal grounds for taking the requested action. A petition for administrative reconsideration can also be filed by any person to challenge a decision made by the Commissioner within 30 days of the decision. The petition should include the decision to be reconsidered, the action the FDA should take, and the legal grounds for taking the requested action.

Formal evidentiary public hearings may be requested by an individual under section 515(g) of the FD&C Act on PMAs and the product development protocols (PDPs). Hearings may also be initiated by the Commissioner to address public concerns about the issuance, revision, or withdrawal of a regulation. A public hearing before a board of inquiry can be held instead of a formal evidentiary public hearing to discuss scientific inquiries pertaining to the issue. A public hearing before a public advisory committee can also be held by the FDA for all matters relating to reviewing a PMA or PDP, review of the Quality System regulation, review of a performance standard for radiation-emitting product by the Technical Electronic Product Radiation Safety Standards Committee, classification of devices under Part 860, and quality standards for mammography facilities. Public hearing before the FDA Commissioner can also be held instead of a formal evidentiary public hearing at the discretion of the Commissioner for the purposes of publicly presenting information on any matter pending before the FDA. A regulatory hearing before the FDA may be held to discuss regulatory matters pertaining to withdrawal of approval of a PMA or repeal of a 510(k) clearance.

mdi Consultants has been involved with many clients on various projects dealing with appealing the FDA’s decision. If you need any assistance with an appeal please contact us for a free consultation.

More information about the processes for hearing, petitions, and requests for supervisory review can be found via https://www.fda.gov/media/128444/download.

We will continue to monitor any future changes moving forward. If you have any questions about significant decisions and the FDA, how this can affect your company, or for any of your regulatory requirements feel free to contact us at info@mdiconsultants.com or use our contact form.