The FDA recently issued a draft Guidance document discussing the available procedures to obtain review of decisions made within its Center for Devices and Radiological Health (CDRH). CDRH is the FDA Center that handles, among other things, applications for pre-market approval (PMA) and pre-market notification (510(k)) of medical devices. Thus, the draft Guidance is useful to medical device manufacturers as a summary of the potential avenues for relief from an adverse decision during consideration of a PMA or 510(k) application. When finalized, the draft Guidance will replace two existing guidance documents, “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” dated February, 1998 and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA,” dated July, 2001.

After emphasizing that the best way to resolve a dispute between the Center and an outside stakeholder (e.g., manufacturer who submitted a PMA or 510(k)) is through discussion and agreement, perhaps with the assistance of the CDRH Ombudsman, the draft Guidance discusses the different options for obtaining review of adverse decisions on which agreement cannot be reached. The first option discussed is a request for supervisory review under 21 C.F.R. § 10.75, the highlights of which are:

• Scope – available for several decisions on PMAs, 510(k)s, Investigational Device Exemptions (IDE), and pre-IDE recommendations, among others
• General – should be directed to level immediately above person making adverse decision; generally should not include new information or may be returned to original decision-maker for further review; review can be refused in some circumstances; “parallel review”, i.e., seeking review of adverse decision while pursuing another path to approval, is discouraged
• Process – requests must be written and submitted within “reasonable” time or risk denial
• Meeting or teleconference – at option of FDA reviewer; to expedite review, submitter can request no meeting, i.e., “paper review”
• Non-final decisions – review is available and typically a paper review
• External expertise – for particularly complex or novel issues, the submitter can request an Advisory Panel of outside experts (noted to be a slow process)
• Format – the draft Guidance includes a recommended (but not required) format

The second option is for the party seeking review to request a Medical Devices Dispute Resolution Panel (DRP). The DRP is an eight-person panel comprised of three standing voting members, three temporary voting members, and two non-voting members representing consumers and industry, respectively, to resolve a scientific controversy. It is only available at the Center level (the second highest step, directly below the FDA Commissioner) and only after an Advisory Panel has weighed in on the dispute. If the request is granted, there is a twelve week process leading up to the DRP meeting and a thirty day process for it to issue its decision. For all these reasons, the DRP option most likely will not be pursued too often.

The third option is a petition to the FDA and the draft Guidance summarizes several types of petitions, including:

• Section 515 Petition for review by Commissioner of a PMA denial
• Citizen Petition under 21 C.F.R. § 10.30 to challenge any FDA action or decision or to request FDA to take certain action
• Petition for Administrative Reconsideration of Action under 21 C.F.R. § 10.33
• Petition for Administrative Stay of Action under 21 C.F.R. § 10.35

Certain types of formal hearings are also available in certain circumstances, including the following:

• Formal evidentiary public hearing under 21 C.F.R. Part 12, upon a party’s request for PMAs or product development protocols (PDP) or for any matter if determined by the Commissioner
• Public hearing before a Board of Inquiry under 21 C.F.R. Part 13 to review medical, scientific, and technical issues
• Public hearing before a public Advisory Committee under 21 C.F.R. Part 14, available for several purposes noted in the draft Guidance
• Public hearing before the FDA Commissioner under 21 C.F.R. Part 15, at the Commissioner’s discretion, to permit people to present information and views on some matter pending before the FDA
• Regulatory hearing before the FDA under 21 C.F.R. Part 16 for matters authorized by statute or regulation, including disapproval of an IDE, withdrawal of approval of a PMA, and rescission of a 510(k) approval

Again, formal hearings may not be the most timely and cost-effective options.

The complete text of the draft Guidance can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm284651.htm  

As always, it is important to remember that FDA Guidance documents (including drafts of course) are not binding on the FDA or industry, but rather represent FDA’s current thinking on a topic.