CDRH strives to foster a working environment that encourages staff to communicate their best professional judgments. The Center’s regulatory decision-making process is designed to allow a variety of perspectives to be considered. In most cases, differences of opinion can be resolved through open and respectful discussion.
Sometimes, however, staff are unable to reach agreement through discussion. In such cases, it’s important to have a clear mechanism in place to ensure that all views are fully considered. For this reason, CDRH established the following Standard Operating Procedure (SOP) for resolving internal differences of opinion related to regulatory decision-making.
- Sets forth the general policy of CDRH with respect to internal differences of opinion related to regulatory decisions;
- Explains the Center’s procedure for resolving such differences of opinion; and
- Defines the roles and responsibilities of Center staff in this process.
As described in the document, if a Center staff member believes it is necessary to pursue higher-level consideration of a regulatory decision in which he or she is involved, he or she should document his or her views in a memorandum and place it in the administrative file related to the matter. The manager reviewing the matter should discuss the issue with the parties involved and attempt to facilitate a resolution. If the parties still cannot reach a resolution, the manager should consider the recommendations and evidence shared and make a decision. Efforts should be made to resolve internal differences of opinion at the lowest organizational level possible. However, if a staff member involved in a disagreement is dissatisfied with the managerial decision, he or she may appeal for further review at a higher level. The document sets forth clear expectations for documentation at each point in the process of resolving a difference of opinion.
This document was issued on May 17, 2013 and supersedes the following documents: "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.
This guidance document provides brief descriptions of processes that external stakeholders may use to request review or appeals of FDA decisions and actions concerning medical devices. The guidance outlines factors to consider in deciding which process is the most appropriate for a particular situation, and possible uses of each process.
Included in this guidance document is a description of the process for convening a Medical Device Dispute Resolution Panel (DRP). The Medical Devices Dispute Resolution Panel 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.
This guidance document, published in 2000, suggests ways to resolve certain "least burdensome" issues, including contacting the CDRH Ombudsman to facilitate a resolution.