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Dispute Resolution Guidance

Persons who wish to have a CDRH decision or action reviewed and reconsidered have a broad array of processes from which to choose, ranging from quick, informal approaches to more formal proceedings. CDRH has developed three guidance documents that focus on dispute resolution processes and procedures:

CDRH Guidance Documents on Dispute Resolution

• MEDICAL DEVICE APPEALS AND COMPLAINTS -- Guidance on Dispute Resolution (February 1998) PDF. This guidance document provides an overview of dispute resolution processes that may be used to obtain review and reconsideration of FDA decisions and actions concerning medical devices. The guidance describes both informal and formal processes, and includes statutory and regulatory citations.

Among the dispute resolution processes described are --

• Internal agency review through the supervisory chain pursuant to 21 C.F.R. 10.75. (This is the most frequently used process and is usually the quickest and most efficient means of resolving a dispute or appeal.)
• Citizen petition
• Petition for administration reconsideration
• Formal evidentiary public hearing
• Public hearing before a board of inquiry
• Public hearing before a public advisory committee
• Public hearing before the FDA Commissioner
• Regulatory hearing
• Civil money penalty hearing.
• The advantages, disadvantages, and possible uses of each process are outlined

See the guidance document for a full list and further details on these and other processes.

• 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 2, 2001). HTML or PDF

  FDA has established this new Dispute Resolution Panel within the Medical Devices Advisory Committee. The CDRH Ombudsman may grant request for review of a scientific dispute by this Panel.

  In addition to serving as a useful forum in which scientific disputes in general can be aired, the Dispute Resolution Panel implements four requirements of the Federal Food, Drug, and Cosmetic Act:

Section 514(b)(5) requires the establishment of an advisory committee to take referrals of any matter concerning the establishment, amendment, or revocation of a performance standard which requires the exercise of scientific judgment.

Section 515(g)(2)(B) requires the establishment of an advisory committee to take referrals of petitions for review of -

the approval, denial, or withdrawal of approval of a premarket approval application, or

the revocation of an approved product development protocol (PDP), a declaration that an approved PDP has not been completed, or a revocation of an approved Notice of Completion that permitted marketing of a device developed under a PDP.

Section 522(b) requires a process to resolve any disputes concerning the need for FDA to order a manufacturer to conduct postmarket surveillance for more than 36 months.

Section 562 requires FDA to provide a procedure for review of all scientific disputes regarding the regulation of medical devices, including review by an appropriate scientific advisory panel, but only to the extent that other provisions of the act or FDA regulations do not already provide a right of review. FDA believes its current procedures already provide methods to obtain review of most, if not all, scientific disputes. The establishment of the Dispute Resolution Panel provides an additional, more focused, procedure for the timely review of scientific disputes.

• A SUGGESTED APPROACH TO RESOLVING LEAST BURDENSOME ISSUES; -- Guidance for Industry (Issued 9/11/2000) Text or PDF

  This Guidance includes suggested ways to resolve certain "least burdensome" issues including contacting the CDRH Ombudsman to facilitate the resolution of these issues.

Updated February 5, 2007

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