3 April, 2014 by David Lim, President and Principal of Regulatory Doctor and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.
We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.
Avoiding a Dispute
The key to avoiding the FDA appeals process is to enhance your awareness and understanding of evolving regulatory issues. It is crucial to establish good knowledge of the perspectives and viewpoints of a given issue between the FDA and the stakeholder. More often than not, issues between the FDA and stakeholders arise from different interpretations and expectations of laws, regulations, rules, policies, scientific and technical requirements and how they should apply to the case on point. It is important to understand the reasoning of the FDA on a particular issue so that a sponsor can effectively address the issues with scientifically sound and justifiable reasons supported by data.
Differences in opinion between the FDA and the stakeholder’s view can be addressed early on in the process through open communication. Here are some practical tips to minimize such differences in perspective early in the process.
- Develop a regulatory plan/strategy early in the process, based on relevant and applicable regulatory requirements with vision.
- Communicate with the Agency early in the process.
- Update the regulatory requirements on a needed basis, as the Agency exercises "flexible decision”
- Stay updated with new or evolving policies and requirements at all times.
- Be proactively aware, flexible and promptly responsive.
- Contact the CDRH Ombudsman
FDA/CDRH Appeals Process
Despite such efforts, stakeholders may disagree with the FDA’s decision or action. We recommend assessing the available FDA appeals process, specifically the FDA’s internal administrative proceedings. On May 17, 2013, the FDA issued the Final Guidance Document, called “Center for Devices and Radiological Health Appeals Processes,” explaining the FDA’s internal appeals processes.1 Depending on the issue at stake, a stakeholder may take one or more of the available avenues, as listed below. Each option serves its own purposes and needs, to be evaluated on a case-by-case basis depending on the individual stakeholder’s situation.
- Request for Supervisory Review under 21 CFR 10.75 (a “10.75 appeal”)
- The Medical Devices Dispute Resolution Panel (“DRP”)
- Judicial Review
1. Request for Supervisory Review under 21 CFR 10.75
A 10.75 appeal is the most commonly used and most time efficient method among the FDA administrative proceedings. Under 21 CFR 10.75, a stakeholder may request internal agency review of a decision through the established agency channel of supervision or review. The agency channel is established as shown in Figure 1.
The timing of such a request depends on whether a decision falls under “significant decision” per section 517A of the FD&C Act. Section 517A was inserted as part of the Food and Drug Administration Safety and Innovation Act of 2012 (“FDASIA 2012”) passed on July 9, 2012.2 Per section 517A(a)(1), the Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of CDRH regarding:
In case of such a significant decision, the aggrieved party must submit a request for a 10.75 appeal no later than 30 days after said decision was made and indicate the type of review, i.e. an in-person or teleconference review. The Secretary then will schedule a review within 30 days after the request. Regarding non-significant decisions, the FDA allows some flexibility, yet it recommends submitting a request for a 10.75 appeal within 30 days as well.
- submission or review of a report under section 510(k);
- an application under section 515; or
- an application for an exemption under section 520(g).
Our recommended best practices for the 10.75 appeal are as follows.
- File an appeal on time – complete and coherent based on the record (e.g., no new information allowed per 10.75(d) unless it is reviewed and agreed by the review authority).
- Address the scientific, technical, clinical and regulatory issues of disputes.
- Avoid raising issues of bias or getting emotional.
- Address the issues in dispute with compelling reasoning of why the appeal should prevail.
- Provide the relief being sought.
- Work for your end goal and relief.
2. The Medical Devices Dispute Resolution Panel (“DRP”)
The DRP is intended to serve as an independent review panel to deal with scientific controversy or dispute between the FDA and the stakeholder.
The main purpose of petitions is to request the FDA to take or refrain from taking an action to reconsider a decision or to place in abeyance an action pending further consideration.
- Petitions under Section 515 of the FD&C Act*
- Petition to request that the Commissioner review the denial of a PMA
- Citizen Petition (21 CFR 10.30)
- Petition for Administrative Reconsideration of Action (21 CFR 10.33)*
- Petition for Administrative Stay of Action (21 CFR 10.35)
- Request for Reconsideration of Adverse Decision on Mammography Facility Accreditation/Certification (21 CFR Part 900, Subpart B)
4. Public Hearing
The guidance document lists five different types of hearings a stakeholder may request. In general, public hearings involve more procedural steps and take more time than other appeals processes. One needs to evaluate carefully when a hearing can be held and what issues can be raised.
- Formal Evidentiary Public hearing (21 CFR Part 12)
- Public Hearing Before A Board of Inquiry(21 CFR Part 13)
- Public Hearing Before A Public Advisory Committee (21 CFR Part 14
- Public Hearing Before The FDA Commissioner (21 CFR Part 15)
- Regulatory hearing Before The FDA (21 CFR Part 16)
5. Judicial Review
It is highly recommended to go through the FDA’s internal administrative proceeding before resorting to legal remedies. A Commissioner will consider a petition for reconsideration only before the sponsor brings legal action. In cases where an issue is subject to pending review under 21 CFR 10.75 or 10.33, or any other administrative process, the Commissioner may request the court to refer the matter back to the Agency or hold its review in abeyance pending completion of administrative reconsideration.
A stakeholder should carefully analyze and consider the FDA’s suggestions when it receives the FDA’s decision. While doing so, stakeholders should choose to pursue further proceedings concerning the issues in dispute, based on reasonable grounds. For example, a stakeholder may try to get a PMA approval based on clinical data largely from outside the US. In response, the FDA requests clinical data, which are statistically powerful and clinically meaningful based on US populations. The stakeholder may elect to go through all the administrative proceedings, including filing a petition for reconsideration. However, in the end, the FDA may still deny the petition. Under this scenario, it is not worthwhile to further pursue a proceeding including a judicial review, and it is recommended to perform a clinical trial based on US populations. For all matters in dispute, it should be carefully analyzed in balance, and assessed based on reasonable facts and situated circumstances on a case-by-case basis. It is recommended to contact and try to work with the CDRH ombudsman’s office.
- Center for Devices and Radiological Health Appeals Processes – Guidance for Industry and Food and Drug Administration Staff, 17 May, 2013.
- Food and Drug Administration Safety and Innovation Act of 2012, 9 July, 2012.
Opinions and conclusions expressed in this article are those of the authors and not those of their respective employers or of any other third party organization.
The information contained in this article is for general guidance on matters of interest only and does not amount to legal advice in any way. Application of laws and the appeal process can vary drastically based on individual facts and surrounding circumstances involved and thus, should be handled on a case by case accordingly. Before making any decision, you should consult an attorney, if needed.
Yoonhee Beatty, J.D. currently works as a Regulatory Affairs Associate at Bard Access Systems, Inc. in Salt Lake City, Utah.
Dr. David Lim, Ph.D., RAC, CQA is President and Principal of Regulatory Doctor (http://www.regulatorydoctor.com). Regulatory Doctor provides practical, actionable, and sustainable solutions/strategies in an integrated, thorough (PASS-IT) manner to the global healthcare industry. As a certified professional for regulatory affairs (RAC) and quality (CQA) and also as a former patent prosecutor licensed to practice in patent cases before the United States Patent and Trademark Office (USPTO), he is familiar with various different types of medical devices, IVD products, biologics, drugs and combination products.
He is a regulatory coach, mentor, FDA consultant, and public speaker for global matters of regulatory affairs, regulatory compliance, quality and clinical affairs. He can be reached by email at firstname.lastname@example.org or by phone at 540-818-2487