Center for Devices and Radiological Health Appeals Processes

Document issued on: May 17, 2013

The draft of this guidance document was issued on December 28, 2011.

This document supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” February 1998 and “Resolving Scientific Disputes Concerning the the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA,” July 2001.

For questions regarding this document, contact David S. Buckles at 301-796-5447 or by electronic mail at [email protected].

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0738 (expires 4-30-2016).

See additional PRA statement in Section 7 of the guidance.

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

Office of the Center Director

Preface

Public Comment

You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Submit electronic comments to http://regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.  Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet.  You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy.  Please use the document number (1742) to identify the guidance you are requesting.

Table of Contents

1. Introduction
2. Request for Supervisory Review under 21 CFR 10.75
   • 2.1 General Considerations
     • 2.1.1. Supervisory Review Hierarchy
     • 2.1.2 Telescoped Review
     • 2.1.3 New Information
     • 2.1.4 Parallel Review
     • 2.1.5 Bias and Retaliation
   • 2.2 Process for Requesting Review
   • 2.3 Review Meeting or Teleconference
   • 2.4 External Expertise
   • 2.5 Format
   • 2.6 Review Conclusion
3. The Medical Devices Dispute Resolution Panel
   • 3.1 Background
   • 3.2 Panel Composition
   • 3.3 Filing a Request to Convene the DRP
   • 3.4 Eligibility Review
   • 3.5 Dispute Resolution Panel Process
4. Petitions
   • 4.1 Petitions under Section 515 of the FDC Act
   • 4.2 Citizen Petition (21 CFR 10.30)
   • 4.3 Petition for Administrative Reconsideration of Action (21 CFR 10.33)
   • 4.4 Petition for Administrative Stay of Action (21 CFR 10.35)
   • 4.5 Request for Reconsideration of Adverse Decisions on Mammography Facility Accreditation/Certification (21 CFR Part 900, Subpart B)
5. Hearings
   • 5.1 Formal Evidentiary Public Hearing (21 CFR Part 12)
   • 5.2 Public Hearing Before A Board of Inquiry (21 CFR Part 13)
   • 5.3 Public Hearing Before A Public Advisory Committee (21 CFR Part 14)
   • 5.4 Public Hearing Before the FDA Commissioner (21 CFR Part 15)
   • 5.5 Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)
6. Judicial Review
7. Paperwork Reduction Act of 1995

Center for Devices and Radiological Health Appeals Processes – Guidance for Industry and Food and Drug Administration Staff

This guidance represents 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.

Center for Devices and Radiological Health Appeals Processes: Questions and Answers about 517A.”

1 However, nothing in this guidance should be construed as constraining the ability of a stakeholder to exercise options for appeal or petition at any time that is permissible under applicable statutory and regulatory provisions.

2.1.2 Telescoped Review

In some situations, 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. Engagement of a next-level supervisor in a matter under dispute does not necessarily disqualify the next-level supervisor from hearing the dispute on appeal; however, elevation of a dispute may be appropriate if the next-level supervisor has been significantly and substantively involved in the regulatory action under review. Certain circumstances may also warrant referral of the review directly to the next-level supervisor, up to and including the Center Director. In these situations, the Center intends that the review will be undertaken and decided by the next-level supervisor.  For example, circumstances such as imminent risk to public health may warrant elevation of a Division-level appeal directly to the Center Director. A stakeholder wishing to elevate a dispute should indicate a request for telescoped review with an accompanying rationale. The decision to collapse two or more levels of review or to elevate a 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.

2.1.3 New Information

A request for review under section 10.75 should be based on the information that was already present in the administrative file at the time of the decision that is being reviewed, as provided in 21 CFR 10.75(d). A submitter can add graphs, simple analyses, or other minor clarifications as part of the request and should clearly identify the information as new and  minor, and the review authority may request such information from either the submitter or from CDRH employees involved in the decision that is being reviewed. If the request as submitted contains significant 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; however, the review authority may, at his or her discretion, allow the introduction of new information in the interest of expediting a decision or reaching an agreement between the stakeholder and the Center. 

2.1.4 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. Generally the Center will contact the company to ask which alternative it prefers. 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 should 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,² 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 5.5 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 section 10.75 request for supervisory review that involves a matter that is under active review by the Office of the Commissioner.

2.1.5 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 interactions with  entities doing business with the Center are free from bias or retaliation at every stage, 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 can be brought to the attention of the Ombudsman. Evidence of bias or retaliation in the form of electronic mail 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 can 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, make a finding as to whether bias and/or retaliation occurred, and determine what, if any, further actions should be taken. 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.

In addition, a stakeholder who believes that they have been subjected to bias or misconduct on the part of CDRH employees may contact the FDA Office of Internal Affairs (OIA) and may also file a written complaint directly with the HHS Office of the Inspector General (OIG). Although the CDRH Ombudsman is available for consultation as desired, there is no requirement for prior interactions within CDRH before contacting OIA or OIG.

³Â  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 2.5 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 2 but without the involvement of the DRP.

⁴ 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;
• a matter not within the purview of the Center, such as designation of lead center for a combination product or a dispute already referred to the Commissioner’s Office; or
• allegations of bias or retaliation by FDA employees.

Special circumstances may warrant a section 10.75 review directly to 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 significant 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.

5 and receives an appeal decision upholding the approvable or not approvable decision, FDA would consider the 10.75 appeal decision to be a new approvable or not approvable decision under 21 CFR 814.44(e) or (f).⁶  Therefore, the applicant may elect to treat this decision as a denial of approval of the PMA under 21 CFR 814.44(e)(2)(ii) or (f)(2), and may file a petition for review under 515(d)(4) within 30 days of such appeal decision.  In this circumstance, the Center will treat the decision as a denial and will issue an order accordingly.  See21 CFR 814.45(e)(3).  To promote an orderly process and coherent administrative record, CDRH discourages contemporaneous appeal processes and generally will not consider a request for review under 21 CFR 10.75 after the filing of a petition for review under 515(d)(4). 

The processes described in section 515(g)(2) are generally lengthy and resource-intensive for both petitioners and FDA, and, as suggested by use of the dispute resolution panel to fulfill the statutory requirement, can be adversarial.  Alternative processes have historically provided a more streamlined pathway for elevating disputes about PMAs.  For these reasons, the procedures provides by section 515(g)(2) have rarely been invoked. 

4.2 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.

4.3 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.

4.4 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.

4.5 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 mammography 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 Standards 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 Standards
Attention: Program Management Branch
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
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 Standards 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 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 5.5.

5. Hearings

Following is a discussion of the types of hearings that parties outside of FDA may request under Agency regulations.  This discussion is not intended to be all-inclusive and should not be construed as recommending for or against any option available to a stakeholder. 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.

Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers about 517A.”

⁶ FDA would not consider an applicant who submits a timely 10.75 appeal of an approvable or not approvable decision to have voluntarily withdrawn its PMA under 21 CFR 814.44(g).