Draft Guidance for Industry and Food and Drug Administration Staff - CDRH Appeals Processes

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.
Document issued on: December 27, 2011

You should submit comments and suggestions regarding this draft document within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit e lectronic comments to http://www.regulations.gov. Identify a ll comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document, contact David S. Buckles at 301-796-5447 or by email at david.buckles@fda.hhs.gov.

When final, this document will supersede “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” 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,” July 2001.

U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of the Center Director

Preface

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number (1742) to identify the guidance you are requesting.

Table of Contents

1. Introduction
2. Bias and Retaliation
3. Request for Supervisory Review under 21 CFR 10.75
   • 3.1 Scope
   • 3.2 General Considerations
     • Supervisory Review Hierarchy
     • Telescoped Review
     • New Information
     • Refusal of Review
     • Parallel Review
   • 3.3 Process for Requesting Review
   • 3.4 Review Meeting or Teleconference
   • 3.5 Review of Decisions That Are Not Final
   • 3.6 External Expertise
   • 3.7 Format
   • 3.8 Review Conclusion
4. The Medical Devices Dispute Resolution Panel
   • 4.1 Background
   • 4.2 Panel Composition
   • 4.3 Filing a Request to Convene the DRP
   • 4.4 Eligibility Review
   • 4.5 Dispute Resolution Panel Process
5. Petitions
   • 5.1 Petitions under Section 515 of the FD&C Act
   • 5.2 Citizen Petition (21 CFR 10.30)
   • 5.3 Petition for Administrative Reconsideration of Action (21 CFR 10.33)
   • 5.4 Petition for Administrative Stay of Action (21 CFR 10.35)
   • 5.5 Request for Reconsideration of Adverse Decisions on Mammography Facility Accreditation/Certification (21 CFR Part 900, Subpart B)
6. Hearings
   • 6.1 Formal Evidentiary Public Hearing (21 CFR Part 12)
   • 6.2 Public Hearing Before A Board of Inquiry (21 CFR Part 13)
   • 6.3 Public Hearing Before A Public Advisory Committee (21 CFR Part 14)
   • 6.4 Public Hearing Before the FDA Commissioner (21 CFR Part 15)
   • 6.5 Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)
7. Judicial Review

Draft Guidance for Industry and Food and Drug Administration Staff

CDRH Appeals Processes

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

1. Introduction

This draft guidance document describes the processes available to outside stakeholders to request additional review of decisions and actions by Center for Devices and Radiological Health (CDRH or the Center) employees. When finalized, this guidance will supersede “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.

Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action; petitions; and hearings. These processes are broadly described in FDA regulations. This draft document provides general information about each process, as well as guidance on how to submit related requests to CDRH and FDA.

Keep in mind as you read over this material that for any situation, multiple processes for resolution may be available. It is up to the party seeking review of an adverse decision or resolution of a difference of opinion to determine the appropriate process for a given circumstance or issue.

The most effective means of resolving a dispute between the Center and an external stakeholder is through discussion and agreement. The Center Ombudsman is available to assist in clarifying issues, mediating meetings and teleconferences, and conducting discussions with the parties in an effort to resolve disagreements short of a formal review or appeal. Before contacting the Ombudsman, a stakeholder should have made reasonable efforts to discuss the decision or action in dispute with the individual charged with managing the matter at issue, for example: the Lead Reviewer in the Office of Compliance for a Warning Letter; the Lead Reviewer in the Office of Device Evaluation or the Office of In-Vitro Diagnostics for pre-market review actions; or the Epidemiologist in the Office of Surveillance and Biometrics for a post-approval study issue. If this is unsatisfactory, it may be necessary or helpful for the relevant Branch Chief and members of Division management to be brought into the discussion. 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 or appeal.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

2. Bias and Retaliation

Handling an appeal or reconsideration of a matter in dispute is a routine part of the Center’s business processes. The Center is strongly committed to ensuring that an entity doing business with the Center is free from bias or retaliation at every stage of interaction, including the filing of an appeal of a Center action. If the submitter of an appeal or request for review believes that Center staff is engaging in bias or retaliation consequent to the submitter filing an appeal or otherwise formally challenging an agency decision, those concerns should immediately be brought to the attention of the Ombudsman. Evidence of bias or retaliation in the form of email messages, meeting or teleconference minutes, or the like, is very helpful in establishing a basis for requesting relief. Contact with the Ombudsman can be on a confidential basis if so requested, in which case the Center will protect the confidentiality of the information provided and the source of such information to the maximum extent possible under governing disclosure laws.

Note that an appeal or review meeting is not intended to be the forum for airing allegations of bias or misconduct. An allegation of bias, misconduct or other wrongdoing should first be discussed with the Ombudsman and then submitted in writing directly to the Ombudsman, accompanied by documentation to support the allegation. The Ombudsman will investigate the allegations and determine what, if any, further actions should be taken. A determination of whether an entity is being subjected to bias and/or retaliation is left to the discretion of the Ombudsman. If after an initial investigation the Ombudsman decides that there is insufficient basis to sustain an allegation of bias or retaliation, the rationale for this determination will be discussed with the complainant, affording an opportunity for further discussion or presentation of additional evidence. If the Ombudsman decides that there is a legitimate basis to support an allegation of bias or retaliation, then the Ombudsman will pursue the matter through independent channels to the Commissioner’s Office. At that point a decision will be made whether to refer the matter for internal investigation.

3. Request for Supervisory Review under 21 CFR 10.75

As mentioned earlier, the most effective means for resolving disputes is through discussion and mediation. If these approaches fail to resolve the disagreement, or if an adverse action is taken, there are several mechanisms available to stakeholders, including hearings, petitions, and requests for supervisory review. Each of these mechanisms is described in this document. Of these, by far the most commonly used is a request for supervisory review under 21 CFR 10.75. Most decisions made by the Center can be revisited under this Section, which is a general-purpose mechanism to request administrative review of a decision that an interested person believes to be incorrect.

This section contains guidelines for filing a request for supervisory review under Section 10.75 and provides a general description of the review process. Internal agency review through the supervisory chain under Section 10.75 is usually the quickest and most efficient means of resolving a dispute relating to a CDRH decision. Through this process, the supervisor of a Center employee will, at the request of an interested or aggrieved party, review a decision or action of the employee and issue a decision. The decision rendered by the review authority customarily takes one of the following forms: declining to conduct the review; overturning the decision of the employee; upholding the employee decision; or, in some circumstances, referring the matter back to the employee for reconsideration under defined conditions. An opportunity may also arise for the review authority to mediate an agreement between the submitter and the employee.

3.1 Scope

Center decisions that can be reviewed under Section 10.75 include, but are not limited to, the issues listed in this section. You can contact the Ombudsman to discuss whether a specific situation or dispute can be reviewed under Section 10.75.

Pre-Market

• Premarket Notification (510(k)): Refusal to Accept; deficiencies cited in an Additional Information letter; Not Substantially Equivalent determination; denial of a de Novo request for automatic reclassification; proposed 510(k) rescission
• Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE): Application Not Filed; deficiencies in a Major Deficiency letter; Not Approvable letter; Denial letter
• Investigational Device Exemption (IDE): Refusal to Accept; Disapproval letter; deficiencies in a Conditional Approval letter; Centers for Medicare and Medicaid Services (CMS) Reimbursement Designation (Category A or B)
• Pre-IDE: recommendations provided in response to a pre-IDE submission
• Response to a Section 513(g) request for classification information

Post-Market

• Warning and Untitled Letters¹
• Application Integrity Policy
• Requirements of a Post-Approval Study
• Imposition of a 522 study, or the conditions thereof
• Request for Additional Information from a Medical Device Report

3.2 General Considerations

Supervisory Review Hierarchy

A request for supervisory review should be directed to the next organizational level above the level at which the decision was made. Therefore, it is important to be aware of the signatory of the decision under dispute so that the request can be directed to the appropriate review authority. The organizational hierarchy varies across Offices, but in general the order is: Branch → Division → Office → Center → Commissioner. For example, a 510(k) Additional Information letter is generally signed by the Branch Chief, so a request for review of deficiencies cited in the letter would be directed to the Division Director. A Not Substantially Equivalent (NSE) letter may be signed by a Division Director or an Office Director, depending on the nature of the determination, so a request for review of that decision would be directed to the Office Director or the Center Director, respectively. Note that the Division, Office, or Center Director may designate a Deputy Director to be their representative as the authority for a request made to that level. In this situation, a request for review heard by a Deputy constitutes a review by that level of the organization. A request for review by the Commissioner’s Office of a decision made at the Center level generally takes the form of a Petition or Appeal under 21 CFR Part 10 as described later in this document. In general, the Agency expects that available options for review up to the Center Director, such as under Section 10.75, will have been exhausted before a Petition is filed with the Commissioner, although in certain cases time frames for preserving an appeal might mandate filing of an appeal to the Commissioner before exhaustion of Center-level review remedies.²

Telescoped Review

In certain unusual circumstances, a supervisor considering a request for review may wish to engage in substantive discussions with individuals at a higher organizational level, such as his/her own supervisor, or others further up the supervisory chain. This may occur, for example, in matters pertaining to regulatory issues, new policy questions, or highly complex scientific questions. These circumstances may also warrant referral of the review directly to the next-level supervisor, up to and including the Center Director. In these rare situations, the Center intends that the review will be considered to have been undertaken by the next-level supervisor, even if the review decision letter has been signed by the supervisor to whom the request for review was originally directed. The decision to collapse two or more levels of review is made solely at the Center’s discretion and the Center intends to document the rationale for the decision in the review decision letter.

New Information

A request for review under Section 10.75 should be based on the information that was already present in the administrative record at the time of the decision that is being reviewed. A submitter can add graphs, simple analyses, or other minor clarifications as part of the request, and the review authority may request such information from either the submitter or from CDRH employees involved in the decision that is being reviewed. However, if the request as submitted contains new information such as additional data that has not been previously reviewed, or substantially different analyses of existing data, then the matter will generally be referred back down to the original level for reconsideration.

Refusal of Review

Every supervisory level within the Center has the discretion to refuse to consider a request for review under Section 10.75. Grounds for refusal may include, but are not limited to, lack of timeliness as described below; that the request lacks merit; or, that the request provides grossly inadequate grounds for reconsideration. In this situation, a letter will be issued denying the request for review without prejudice and stating the reasons for refusal. The submitter then has the option to either revise and resubmit the request or to refer the request to the next supervisory level.

Parallel Review

In some circumstances, a company with a request for review pending with the Center may wish to engage in a discussion with the review team with the goal of resolving the issues under dispute before the review process is completed. Alternatively, a company requesting review of a regulatory decision on a marketing application may submit a new application while the review of the previous decision is pending. These circumstances are sometimes called “parallel review”. The Center strongly discourages this approach, 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. A company with a pending request for review should refrain from direct communication with the review team while the request is being considered; alternatively, if a company has filed a request for review and subsequently wishes to engage in a discussion with the review team in an effort to resolve the dispute, then the request can be withdrawn without prejudice.

In addition, because the filing of a request under Section 10.75 does not stay other administrative or enforcement actions by the agency,³ the matter that is the subject of the request for supervisory review may also be under review in other administrative proceedings, such as a Part 16 hearing described in section 6.5 of this document, or even a Civil Money Penalty proceeding. Similarly, an interested person may seek other forms of review during the pendency of a request under 10.75, such as reconsideration by the Commissioner under 21 CFR 10.33. However, the Center will generally decline to consider a 10.75 request for supervisory review that involves a matter under review at the Office of the Commissioner unless that review authority refers the matter back to the Center for review.

3.3 Process for Requesting Review

The submitter of the request should submit two written copies of the request to the Document Mail Center (DMC) as follows: 

U.S. Food and Drug Administration
Center for Devices and Radiological Heath
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

An additional copy of the request can be sent to the CDRH Ombudsman at the following address. An additional copy should be included for requests to the Center Director, but is optional for all other requests:   

CDRH Ombudsman     
Center for Devices and Radiological Health 
U.S. Food and Drug Administration 
WO66 Room G414
10903 New Hampshire Avenue  
Silver Spring, Maryland 20993-0002  

Requests made to the Office of Device Evaluation and the Office of In-Vitro Diagnostic Device Evaluation and Safety (OIVD) of pre-market decisions are generally managed by designated individuals such as Regulatory Advisors. Requests made to other Offices are managed by the office of the individual who made the decision at issue, while requests to the Center Director are managed by the Office of the Ombudsman. The individual who is managing the review will contact the submitter to acknowledge receipt and to make arrangements as appropriate. This individual will also serve as the point of contact for the submitter during the review process, and while the review is in progress, all requests or inquiries should be directed to that individual.

There are no statutory or regulatory timeframes for filing a request for review under 21 CFR 10.75, or for FDA to issue its response to such request. However, failure to file a request within a reasonable time period following a decision by CDRH may complicate the Center’s response to the request and disrupt Center processes. For this reason, the Center recommends that requests should be filed within sixty days of the decision for which review is sought. Failure to file a timely request may result in denial of the request. In general, a review meeting or teleconference, if one is to be held, is scheduled within four to six weeks of receipt of the written request for review, and a decision rendered and communicated to the submitter within six weeks after receipt of the request or six weeks after the review meeting, if one is held. Reviews involving referral to external expertise generally take longer. Except in special circumstances, reviews are managed and considered in sequence, in the order in which they are submitted. If the submitter is dissatisfied with the decision rendered, then the matter can be submitted for further review to the next supervisory level, up to the Center Director.

3.4 Review Meeting or Teleconference

At the option of the review authority, there may be a meeting or teleconference to allow the submitter to present its case directly. If a meeting or teleconference does take place, the Center intends the meeting to be a direct interaction between the submitter and the review authority. One or more members of the review team and Branch Chief or other appropriate member of management should be present at the meeting; however, since the meeting is the submitter’s opportunity to make its case, interactions between the review team and the submitter should be managed by the review authority to ensure that the submitter has an unfettered opportunity to state its case. Note that one possible outcome of a review meeting is for the review authority to negotiate a mediated agreement between the parties, should an appropriate opportunity arise. The Ombudsman is present at review meetings at the Center level. A submitter or member of the review team may request that the Ombudsman be present at other review meetings; however, it is within the Ombudsman’s discretion whether to attend.

To expedite resolution in cases where the submitter believes the circumstances of the decision subject to review can be presented effectively in writing, the submitter may elect to request that the review meeting not be held, and, instead, request that the review be considered on an expedited basis. This is sometimes referred to as a “paper review” in that the dispute is considered on the merits of the administrative file and the review package filed by the submitter.

3.5 Review of Decisions That Are Not Final

A number of decisions made by the Center that are subject to review under 21 CFR 10.75 are not final actions or do not represent final decisions. This includes, for example, 510(k) requests for Additional Information (AI letters), disputes within a Pre-IDE submission, Warning Letters, and requests for Additional Information associated with an adverse event report (MDR). In general, requests for review of these types of intermediate decisions that are not final are handled as “paper reviews” to streamline the process for these reviews. If the submitter of a request for review of a decision that is not final believes that special circumstances pertain and that a meeting or teleconference is warranted, a justification for the request should be included explicitly in the review package. A decision to grant a meeting or teleconference is at the discretion of the review authority. Also, the review authority retains the option to request an in-person meeting or teleconference with the submitter, pursuant to investigating the circumstances of the decision that is the subject of the review.

3.6 External Expertise

In matters that are particularly complex or novel, the submitter may request that the review authority refer the dispute to an Advisory Panel to make a recommendation to the review authority. A decision to convene an Advisory Panel to consider a Section 10.75 request for review is at the discretion of the review authority. Note that this process differs from the procedure for requesting a meeting of the Medical Devices Dispute Resolution Panel for an appeal to the Center level, which is described in Section 4 of this document.

A more efficient means to obtain an external opinion on a matter in dispute is to request that the review authority consider referring the matter to one or more external Subject Matter Experts (SMEs), such as Special Government Employees qualified to participate on Advisory Committees/Panels, to evaluate the matter in dispute and provide advice to the review authority. In this process, a document is drafted by the review authority that states the issue(s) in dispute and includes relevant documents for review. The document is assigned to the SMEs who, in turn, provide their assessment of the issues in writing to the review authority. The written responses of the SMEs become part of the administrative file for the review authority to consider when rendering a decision.

Because of the resources required to convene an Advisory Panel or secure the expertise of an external consultant, CDRH uses external experts only in unusual circumstances generally involving highly complex scientific matters, and generally only after the request for review has been considered at the Office level and has come to the Center level for review. Referral of a request for review to external expertise may substantially lengthen the amount of time required to render a decision.

3.7 Format

The format for a request for review submitted under the provisions of Section 10.75 is not specified by regulation, and submitters may format the request to meet their needs. While there is flexibility in the format of a review under Section 10.75, this section describes a general-purpose format that has tended to be an effective means for conveying a review request. The descriptions in this section are guidelines intended to facilitate the Center’s timely processing of requests for review. Failure to follow these guidelines does not disqualify the request from review as long as the request contains sufficient information to permit review by the review authority, and the submitter may use any format that best suits his/her needs.

A useful format for a review package consists of a four to six page executive summary in narrative form as a cover letter, together with copies of relevant documents cited in the executive summary as references or appendices. The executive summary can be organized in sections as follows:

• A statement that a review is being requested with (level of review, e.g., Director of the Office of Device Evaluation) in the matter of (510(k) or PMA number; post-approval study, etc.) under 21 CFR 10.75;
• A request for either an in-person meeting or a teleconference to provide the submitter an opportunity to make the case directly to the review authority, or a request for expedited review without a meeting or teleconference;
• If desired, a request for the review authority to convene a meeting of the relevant Advisory Panel, or a request for referral of the review to outside expertise in the form of a “homework assignment” along with a justification for either such request;
• A clear statement of the issue in dispute and a discussion of why the request for review should be granted.

The executive summary should conclude with an explicit statement of the action being requested; e.g., reconsideration of a specific request for information or the overturning of an NSE determination or a Not-Approvable letter. If there is an acceptable alternative to a complete reversal of the decision being challenged, such as referral of the matter back down to the review team for reconsideration under specific conditions, that should be stated in the conclusion. As stated earlier, the review must be based only on the information already in the administrative file at the time of the decision that is the subject of the review.

3.8 Review Conclusion

The review process is concluded with the issuance of a decision letter. The letter describes the basis for the request for review, conveys the decision of the review authority, and explains the basis for the decision. The letter may also contain recommendations for further actions to resolve the matter(s) in dispute and may describe options for further review or appeal, should the submitter be dissatisfied with the outcome. If the decision is to refuse to consider the request, the reason for refusal will be described.

4. The Medical Devices Dispute Resolution Panel

4.1 Background

The Medical Devices Dispute Resolution Panel (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 Devices Advisory Committee Charter and the processes that apply to Medical Devices Advisory Committees generally apply to the DRP except as described in this document. The DRP fulfills two statutory mandates under the Federal Food, Drug, and Cosmetic Act (FD&C Act): the requirement of section 515(g)(2)(B) for review of PMA approvals and denials by an advisory committee “which may not be panels under section 513;” and the requirement of section 562 for a process for review of scientific controversies by a sponsor, applicant, or manufacturer of a drug or device product for which no other section of the FD&C Act “provides a right of review of the matter in controversy….”

There are two general circumstances under which CDRH may convene a meeting of the DRP to provide advice to the Center:⁴

• As directed by the Center Director to provide advice on a scientific controversy or a matter in dispute that has come to the attention of the Center Director; or,
• Upon approval of a request by a stakeholder as part of an appeal to the Center level.

The latter circumstance is described in more detail in this document.

4.2 Panel Composition

Pursuant to the charter of the Medical Devices Advisory Committee, the DRP has five standing members, who are generally appointed for four-year terms, and three temporary members, as follows:

• Three standing voting members, including the Panel Chair, who are chosen for their general scientific expertise applicable to a wide range of issues;
• A non-voting member representing consumer interests;
• A non-voting member representing industry interests;
• Three temporary voting members who are chosen for their specific expertise and experience in the matter under consideration by the DRP.

Although each DRP meeting will include at a minimum the eight members described above, additional temporary voting or non-voting members may be included on each Panel roster to provide specific expertise as needed. Temporary panel members, including consultants, may be drawn from members of other Advisory Panels or may be Special Government Employees or other qualified consultants. Temporary panel members are typically selected specifically for expertise appropriate to each DRP panel meeting. Individuals who previously had substantial involvement in the matter under review, such as participation on a relevant Advisory Panel, are not eligible. Although interested parties will be apprised of the selections prior to the panel meeting, the individuals are chosen by FDA to ensure freedom from bias or conflicts and to ensure that appropriate expertise is represented on the panel. Concerns regarding the individuals selected as temporary voting members can be expressed in writing to the Ombudsman, who will investigate these concerns and note them in the administrative record of the DRP proceedings.

4.3 Filing a Request to Convene the DRP

An interested party who wishes to submit a request for review to the Center level may request that the DRP be convened to consider the dispute and make a recommendation to the Center Director. As with a request for a review authority to convene an Advisory Panel, a request to convene the DRP should be made within the context of a request for review by the Center level under Section 10.75.⁵ A review request that includes a request to convene the DRP should generally be submitted within 30 days of the date of the action that is the subject of the dispute, although an extension for a defined time period may be requested from, and granted by, the Ombudsman. The format of this request can follow the guidelines described in this document in Section 3.7 and should include an explanation of the basis for the request. The Deputy Center Director, in consultation with the Ombudsman, will decide whether to grant the request and will convey the decision to the submitter, normally within 15 days of receipt of the request. If the request is denied, then the Section 10.75 review process will go forward as described in Section 3 but without the involvement of the DRP.

4.4 Eligibility Review

A request to convene the DRP should meet the following criteria:

• The submitter should have exhausted other review options through the supervisory chain below the Center level; for instance, a Section 10.75 request for review to the relevant Office Director;
• If the DRP is included in a Section 10.75 request for review made to the Center, the matter under dispute should already have been the subject of an Advisory Panel meeting;
• The issue should primarily concern a scientific controversy⁶ and should not involve:
  • a regulatory, legal, or statutory authority dispute;
  • actual or alleged criminal activity;
  • regulatory jurisdiction, such as Designation of Lead Center for a combination product; or
  • allegations of bias or retaliation by FDA employees.

Special circumstances may warrant a Section 10.75 review directly by the Center level, including a request to convene the DRP, before the review options at the Division and Office levels have been exhausted. These situations may include, for example, an issue that is of immediate interest or impact to the public health, such as an innovative device intended to treat critically ill members of a vulnerable patient population for whom no other viable treatment alternative exists. If a stakeholder believes that such special circumstances exist, the matter should be discussed expeditiously with the Ombudsman.

4.5 Dispute Resolution Panel Process

As mentioned earlier, except where a different process is described in this section, the process for the DRP generally conforms with the process for FDA’s Medical Devices Advisory Committee. Once a decision has been made to convene the DRP, the sequence of events described in this section is initiated. The sequence of events may be modified on an ad hoc basis as circumstances warrant for a specific Panel meeting.

• 12 weeks prior to meeting: Ombudsman drafts Summary of Scientific Issues in Dispute and sends copies to parties for comment⁷;
• 12 weeks prior to meeting: Temporary panel members are selected;
• 10 weeks prior to meeting: the parties involved in the dispute should submit an electronic copy of the index of materials each intends to include in their separate Panel Packs.⁸ When both parties have submitted the materials, the Ombudsman will exchange the materials between the parties;
• 9 weeks prior to meeting: parties should provide to Ombudsman any objections to inclusion of specific documents in their respective indices;
• 8 weeks prior to meeting: two electronic copies of complete Panel Packs (in draft form) should be submitted for Ombudsman review and comment. When materials from both parties are received, the Ombudsman will share materials with both parties. Although neither party may suggest, insist on, or negotiate corrections or revisions to the other party’s materials, specific objections may be filed with the Ombudsman, who may elect to include some or all of the objections in the materials provided to the panel members;
• 6 weeks prior to meeting: twenty (20) hard copies and twenty (20) CDs or other electronic media of each party’s final Panel Packs should be submitted. The Ombudsman will review⁹ the panel briefing materials for distribution and will share the materials with both parties. Each party should also submit in PDF format redacted and unredacted versions of the panel briefing materials for forwarding to the Freedom of Information (FOI) Office for review and for the Division of Dockets Management. The Ombudsman will forward the unredacted panel briefing materials to the panel members; however, the sponsor may request that only a redacted copy of the Panel Pack be provided to the panel Industry Representative. (see footnote 8)
• 10 business days prior to meeting: the parties should submit one hard copy and one electronic copy of slides. When materials from both parties are received, the Ombudsman will share the materials with both parties. The Ombudsman will review (see footnote 89) the presentations and will then forward the materials to the panel members. No substantive changes may be made to the slides after they have been sent to the panel members.

During the panel meeting, the sponsor will speak first, followed by FDA and then by other affected or interested parties. Each party may be accompanied by advisers or scientific experts. During the meeting, members of the DRP may question the parties directly; however, no questioning by or debate between the parties should be permitted. Once deliberations have been completed, the Chair will determine whether consensus exists among the panel members and, if not, will call for a vote. The Chair will not vote except to cast a tie-breaking vote. As with other Advisory Committee meetings, FDA will provide a transcription of the DRP meeting.

Within 15 days of the panel meeting, the Panel Chair will prepare a draft Statement of Findings and a draft Recommendation on the disposition of the issues under consideration, including any minority views. The draft documents will be provided to each panel member, who will then have 10 business days to provide comments and recommendations for edits to the Chair. Five days thereafter, the Chair will sign the final version of the documents. These documents will be issued to the Center Director (or FDA Commissioner, as applicable) who will make the final decision.

5. Petitions

Petitions can 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 the Citizen Petition and the Request for Administrative Reconsideration.

5.1 Petitions under Section 515 of the FD&C Act

As provided in Section 515(d)(4), an application whose Premarket Approval Application (PMA) has been denied may file a petition to request that the Commissioner review the denial. Also under this Section, any interested person may request review of a PMA Approval Order. Petitions under Section 515(d)(4) are reviewed as described in Section 515(g) and are typically filed as Petitions for Administrative Reconsideration under 21 CFR 10.33, which is described further in this document in Section 5.3. Section 515(g)(2)(B), which provides for referral of petitions under this Section to an advisory committee, has been implemented by CDRH with the establishment of the Medical Devices Dispute Resolution Panel as described in Section 4. Section 515(d)(4) requires that such petitions be filed within 30 days of the date of receipt of the denial of a PMA.

5.2 Citizen Petition (21 CFR 10.30)

A citizen petition can be submitted by any person to challenge an FDA action or decision, or to request an action from FDA. Citizen petitions must conform to a specific format and must provide certain information. These requirements are explained in detail at 21 CFR Part 10, subpart B, and these regulations should be carefully reviewed before preparing and submitting a citizen petition. Among the informational items that must generally be included are:

• A citation of the statutory provisions upon which the petition is based (if known);
• A complete description of the action requested, including the exact wording of any proposed regulation or order;
• A statement of the factual and legal grounds for taking the requested action;
• Information on any environmental impact; and
• Certification that the petition includes the full information and views relied upon.

FDA may also request information on the economic impact of the requested action if it appears it would result in a significant economic impact.

A citizen petition must be filed with FDA’s Division of Dockets Management, the mailing address for which can be found on the FDA Web site at: http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

5.3 Petition for Administrative Reconsideration of Action (21 CFR 10.33)

A petition for administrative reconsideration can be filed by any person with regard to part or all of a decision of the Commissioner. In accordance with 21 CFR 10.33, the petition must be filed within 30 days of the decision involved. A petition submitted later will ordinarily be denied as untimely, although the FDA Commissioner has discretion to permit a petition to be filed after 30 days when there is good cause to do so.

A petition for administrative reconsideration must conform to a specific format and must provide certain information. These requirements are explained in detail at 21 CFR 10.33 and 10.20 and these regulations should be carefully reviewed before preparing and submitting a petition.

The petition must include:

• A statement of the decision to be reconsidered;
• The action FDA should take if the petition is granted; and
• The legal and factual grounds relied upon, including identification of relevant information and views that the petitioner contends were not previously or adequately considered when the decision was made.

No new information or views can be submitted in a petition for administrative reconsideration. The petition must be based exclusively on information in the administrative record on which the decision was made.

A petition for administrative reconsideration may be granted and the decision reconsidered if the FDA determines doing so is in the public interest and in the interest of justice. A petition for administrative reconsideration will be granted if FDA finds all of the following criteria have been met:

• The petition demonstrates that relevant information or views in the administrative record were not previously or not adequately considered;
• The position of the petitioner is not frivolous and is sought in good faith;
• The petition demonstrates sound public policy grounds for reconsideration; and
• Reconsideration is not outweighed by public health or other public interests.

Note that the granting of a petition for reconsideration means only that reconsideration will occur, not that the Commissioner has decided in favor of the petitioner. A petition for administrative reconsideration must be filed with FDA’s Division of Dockets Management, the mailing address for which can be found on the FDA Web site at: http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

5.4 Petition for Administrative Stay of Action (21 CFR 10.35)

Under Section 10.35, the Commissioner may elect to place in abeyance or extend the effective date of any action pending or following a decision on any matter. The stay may be requested to be indefinite or for a defined time period. A request for a stay must be filed within 30 days of the action for which the stay is requested, although the Commissioner may allow a petition after 30 days for good cause. A request under this Section should clearly state the action for which the stay is requested as well as the grounds for requesting the stay. Note that, as is true of all administrative procedures under 21 CFR Part 10, the submission of a petition under Section 10.35 does not, in itself, effect a stay of any administrative action, including enforcement action. A request for a stay of action should be filed with the Division of Dockets Management as described above. The Commissioner’s decision on the petition will be published in the Federal Register if the original action was so published.

5.5 Request for Reconsideration of Adverse Decisions on Mammography Facility Accreditation/Certification (21 CFR Part 900, Subpart B)

Under the Mammography Quality Standards Act (MQSA) (42 U.S.C. § 263b), all U.S. medical facilities offering mammographic services must meet certain national quality standards and be certified by FDA following accreditation by an accreditation body (AB), which in turn has been approved by FDA. Any facility that has been denied accreditation is entitled to appeal the decision directly to the AB that rendered the decision. If the appellant facility cannot achieve satisfactory resolution of an adverse accreditation decision that precludes certification or recertification through a direct appeal to the AB, it may request reconsideration of the adverse decision by the Division of Mammography Quality and Radiation Programs at the address shown below. Any such request for reconsideration must be submitted within 60 days of an adverse appeals decision by the AB. (See 21 CFR 900.15(d)(3)). Also, during the appeals process and reconsideration period, the appellant facility is not permitted to provide mammography services.

Three copies of a request for reconsideration should be directed to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Division of Mammography Quality and Radiation Programs
Attention: Accreditation and Certification Branch
10903 New Hampshire Avenue
WO66-4675
Silver Spring, MD 20993
Phone: 301-796-5710
Fax: 301-847-8502

Included with a reconsideration request must be the AB’s original denial of accreditation (including clinical or phantom image score sheets, when applicable), all information submitted by the facility to the AB relevant to the appeal (including all original films submitted to the AB), a copy of the AB’s adverse appeals decision (including clinical or phantom image score sheets, when applicable), and a statement of the bases for the facility’s disagreement with the AB’s decision.

Within 60 days after receipt of a reconsideration request, the Division of Mammography Quality and Radiation Programs intends to issue a decision and notify the facility in writing of the decision and the facility’s options as a consequence of the decision. A facility that is dissatisfied with the Division’s decision following reconsideration is entitled to a formal hearing before the Departmental Appeals Board, Department of Health and Human Services.

Procedures are described in 21 CFR 900.15(d). Copies of regulations are available from the U.S. Government Printing Office. They may also be found and downloaded by accessing the CFR on the Internet at: http://www.gpoaccess.gov/cfr/index.html and searching CFR titles and volumes.

A facility that wishes to challenge an order suspending or revoking an FDA certificate that was issued under authority of the MQSA may do so in a Part 16 hearing, in accordance with 21 CFR 900.14. This process is described further in Section 6.5.

6. Hearings

Following is a discussion of the types of hearings that parties outside of FDA may request under agency regulations. The availability of a hearing in any instance depends upon the specific circumstances of the case. A person interested in filing a request for a hearing should be aware that hearings may involve more procedural steps and take more time than other processes such as petitions and Section 10.75 reviews as described previously. A request for a hearing should be filed with FDA’s Division of Dockets Management, the mailing address for which can be found on the FDA Web site at: http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

6.1 Formal Evidentiary Public Hearing (21 CFR Part 12)

A formal evidentiary hearing under 21 CFR Part 12 is available under the following circumstances:

• A person may request a formal evidentiary public hearing under the laws specified in 21 CFR 10.50, including section 515(g) of the FD&C Act on premarket approval applications (PMAs) and product development protocols (PDPs); or
• The Commissioner concludes that it is in the public interest to hold a formal evidentiary hearing on any matter before FDA.

A Part 12 hearing involving the issuance, amendment, or revocation of a regulation is initiated by the Commissioner, through a petition in the form specified in Part 12 or as described for a Citizen’s Petition under 21 CFR 10.30(h).

Hearing requests concerning the issuance, amendment, or revocation of a regulation must be submitted on or before the 30 th day after the date of publication of a final regulation or the 30 th day after publication of a notice withdrawing a proposal initiated by a petition under 21 CFR 10.25(a). If the hearing request involves the issuance, amendment, or revocation of an order (e.g., an order under section 515(g) of the FD&C Act), the request must be submitted within 30 days after the issuance of a notice of opportunity for hearing. (See 21 CFR 10.33(b)).

The Commissioner will review all filed requests for hearings as soon as possible and determine whether a hearing has been justified and whether other actions are appropriate.

A person with a right to a Part 12 hearing may waive that right and instead request a public hearing under Part 13, Part 14, or Part 15, all of which are described below. Part 12 discusses in detail the applicable procedures when a Part 12 hearing commences, including procedures for the submission of pleadings, prehearing conferences, presentation of evidence, and filing of motions. In general, two copies of any submissions, such as pleadings, are to be filed with the Division of Dockets Management per 21 CFR 12.80 and, in general, should conform to the requirements of 21 CFR 10.20.

6.2 Public Hearing Before A Board of Inquiry (21 CFR Part 13)

A hearing under Part 13 is held at the discretion of the FDA Commissioner, when specifically authorized by regulation, or as an alternative to a formal evidentiary public hearing. Generally, the purpose of such a hearing is to review medical, scientific and technical issues; the proceedings are conducted as a scientific inquiry and not a legal trial. The proceedings are informal and the rules of evidence do not apply. A notice of hearing will be published in the Federal Register, and submissions to the Board of Inquiry are to be filed with the Division of Dockets Management, as described previously, and generally served on each participant in the proceeding.

6.3 Public Hearing Before A Public Advisory Committee (21 CFR Part 14)

A hearing under Part 14 is held at the discretion of the FDA Commissioner, or when provided by law or regulations, or as an alternative to a formal evidentiary hearing. Hearings are available under this Part for, among other things, matters relating to the:

• review of a performance standard for a radiation-emitting electronic product by FDA’s Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC);
• classification of devices under Part 860;
• establishment, amendment or revocation of a performance standard;
• review of a PMA or PDP;
• review of the Quality System (formerly Good Manufacturing Practice) regulation;
• establishment of minimum national uniform quality standards for mammography facilities.
• Note that all meetings of the Medical Device Advisory Committee panels are held under Part 14. FDA will publish a notice in the Federal Register of advisory committee meetings. In general, ten copies of written submissions to a committee are to be sent to the executive secretary unless otherwise specified in the Federal Register notice. (See 21 CFR 14.35(a)). Submissions for a Public Hearing under Part 14 do not need to be sent to the Division of Dockets Management.

6.4 Public Hearing Before the FDA Commissioner (21 CFR Part 15)

A hearing under Part 15 is held at the discretion of the Commissioner, when provided by law or regulation, or as an alternative to a formal evidentiary hearing (where granted in the discretion of the Commissioner), to permit persons to present information and views at a public hearing on any matter pending before the FDA. Examples of issues that can be referred to a Part 15 hearing include, but are not limited to, the following:

• Proposals to allow persons to order custom devices;
• Proposed Quality System (formerly Good Manufacturing Practice) Regulation;
• Proposed exemptions from federal preemption of state and local device requirements (21 CFR 808.25(e)).
• FDA will publish a notice of hearing in the Federal Register. The scope of a hearing is determined by the notice of hearing and any regulation under which the hearing is held. A person may submit information or views on the subject of the hearing in writing to the Division of Dockets Management as described previously. (See 21 CFR 15.25).

6.5 Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)

A hearing under Part 16 is called at the discretion of the FDA Commissioner when considering regulatory action, or when provided by law or regulation. Part 16 provides an opportunity for a regulatory hearing on various matters, including but not limited to:

• Sections 520(g)(4) and (g)(5) of the FD&C Act, relating to disapproval of an Investigational Device Exemption, or notice of a proposed withdrawal of approval;
• 21 CFR 814.46(c), relating to withdrawal of approval of a PMA;
• Rescission of a 510(k) clearance;
• An order suspending or revoking an FDA certificate issued to a U.S. mammography facility pursuant to the MQSA.
• A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. A person offered a hearing has the amount of time specified in the notice to request a hearing. Under 21 CFR 16.26(a), a request for a hearing may be denied if the request fails to demonstrate a genuine and substantial issue of fact that warrants a hearing; therefore, the request should specify the grounds for the hearing request. FDA and the party requesting the hearing will, if feasible, at least one day before the hearing provide to each other written notice of any published articles or written information to be presented or relied on at the hearing. A regulatory hearing is informal and the rules of evidence do not apply. (See 21 CFR 16.60(c)).

7. Judicial Review

FDA is frequently asked about judicial remedies. A party seeking judicial review of a final action taken by FDA should consult its attorney or perform its own research of applicable statutes and regulations. It is not appropriate for FDA to offer advice or assistance concerning whether, and how, a party may seek review of an adverse decision in court. In general, FDA believes it is in the public interest for parties to avail themselves of administrative remedies first, so that FDA has the opportunity to reconsider and review any dispute concerning an FDA action before it is subject to judicial review. (See 21 CFR 10.45). In the event that a petitioner brings judicial action relating to a matter that is subject to a pending review under 21 CFR 10.75 or 10.33, or any other administrative process, the Commissioner may request that the court refer the matter back to the Agency or hold its review in abeyance pending administrative reconsideration. (See 21 CFR 10.33(h)). Moreover, the Commissioner will generally consider a petition for reconsideration only before the petitioner brings legal action in the courts.

¹ This applies to actions initiated by CDRH. Warning Letters or other actions taken by the other Centers, by District Offices or by the Office of Regulatory Affairs (ORA) should be submitted for review or otherwise appealed to those Offices or Centers. Warning and Untitled Letters provide a mechanism for responding to the issues, typically within 15 or 30 days. The Center expects that this mechanism will have been exhausted prior to requesting review under Section 10.75; otherwise, the request may be denied until such action has been completed.

² For example, a sponsor of a PMA that has been disapproved may file a petition for review of such denial on or before the thirtieth day after receipt of the notice of denial. See section 515(d)(4) of the FD&C Act.

³ See 21 CFR 10.35 for requests for stays.

⁴ As described in section 5 of this document, the DRP may also be convened to provide recommendations to the Office of the Commissioner on a request for reconsideration of approval or denial of a PMA.

⁵ A request to convene a meeting of the DRP may also be part of a petition under 21 CFR 10.33, as described in Section 5.3.

⁶ This condition may be interpreted broadly so as to allow the DRP to consider a range of issues that may be associated with a scientific dispute. For example, a scientific dispute regarding clinical evidence may also involve questions regarding the need for a training program, which could be considered by the DRP within this broader context.

⁷ In preparing the final version of the Summary of Scientific Issues, the Ombudsman will take into account any comments received on the initial draft. Comments or issues raised that are not included in the final version may be captured in the administrative record of the panel proceedings.

⁸ The information in the Panel Pack should conform to the recommendations in the FDA guidance document, “Advisory Committee Meetings — Preparation and Public Availability of Information Given to Advisory Committee Members” dated August 2008.

⁹ At various stages in the process the Ombudsman will screen materials for inappropriate content, including, but not limited to, new information not already present in the administrative record; material concerning non-scientific issues such as regulatory and legal questions; and, personal, intemperate, or inappropriate language. The Ombudsman will request the party submitting inappropriate content to remove same. The Ombudsman will highlight any inappropriate content not removed from final materials as content the Panel members are to disregard in their deliberations.