New FDA Guidance on Appeals Processes for Medical Device Denials

May 21, 2013

On May 17, 2013, FDA’s Center for Devices and Radiological Health (CDRH) published new guidance on maneuvering through the medical device appeals processes, “Center for Devices and Radiological Health Appeals Processes — Guidance for Industry and Food and Drug Administration Staff” (Guidance). The new Guidance supersedes older ones from 2001 and 1998. The Guidance outlines multiple formal and informal methods of resolving a dispute with the FDA. FDA’s baseline position is that “[t]he most effective means of resolving a dispute between the Center and an external stakeholder is through discussion and agreement.” The Guidance received a mixed response from industry stakeholders and representative groups.

The five main methods of resolving disputes with from least to most formal are:

  1. Request for Supervisory Review. Internal agency review is usually the quickest and most effective means of formally resolving a dispute relating to a “significant decision” taken by the Center. A “significant decision” includes a not substantially equivalent finding under the 510(k) process; denial of a PMA application; denial of an IDE; or failure to reach an agreement on a protocol during an Agreement Meeting. CDRH strongly discourages parallel review, both because of the resources required to support the duplication of effort and because of the potential for confusion in reviewing a decision that is still under discussion and may be modified.
  2. Medical Devices Dispute Resolution Panel (DRP). The DRP is intended to provide a means for independent review of a scientific controversy or dispute between a stakeholder and FDA. The DRP operates under the provisions of FDA’s Medical Device Advisory Committee Charter and the processes that apply to Medical Devices Advisory Committees generally apply to the DRP. A request to convene the DRP should be submitted within 30 days of the action that is the subject of the dispute.
  3. Petitions. Petitions may be filed to request that the Agency take or refrain from taking an action, to reconsider a decision or to place in abeyance an action pending further consideration. The most common petitions are Citizen Petitions and a Request for Administrative Reconsideration. Citizen Petition must conform to a specific format and provide certain information, including the exact wording of any proposed regulation or order. A Request for Administrative Reconsideration can be filed by any person with regard to part or all of the decision of the FDA.
  4. Hearings. The availability of a hearing in any instance depends upon the specific circumstances of the case. Filing a request for a hearing may involve more procedural steps and take more time than other appeals processes. There are a variety of types of hearings including: (i) a formal evidentiary hearing (Part 12 hearing); (ii) a public hearing before a Board of Inquiry (Part 13 hearing); (iii) a public hearing before a Public Advisory Committee (Part 14 hearing); (iv) a Public Hearing before the Commissioner.
  5. Judicial Review. The FDA believes it is in the public interest for parties to exhaust all administrative remedies within the FDA before engaging in litigation. For certain judicial actions, the Commissioner may request that the court refer the matter back to the FDA or hold its review pending completion of an administrative reconsideration.

If you are considering appealing an Agency decision on your medical device or have general questions regarding one of the appeals processes, please contact one of the authors.