Resolution of Differences of Opinion

• Resources for CDRH Staff
• Resources for Individuals Outside of FDA

Resources for CDRH Staff

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.

Center for Devices and Radiological Health (CDRH) -- Standard Operating Procedure (SOP) for Resolution of Internal Differences of Opinion in Regulatory Decision-Making

This document:

• 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.

Summary:

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.

Resources for Individuals Outside of FDA

1. Medical Device Appeals and Complaints: Guidance On Dispute Resolution *

This guidance document, published in 1998, 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.

 * NOTE (10/01/2009): Some of the information in this guidance – particularly contact information – is out of date. A revised version of the guidance will be posted in the near future.

2. 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

This guidance document, published in 2001, sets forth operational guidelines for the Medical Devices Dispute Resolution Panel, a part of the Medical Devices Advisory Committee. As described in the document, the CDRH Ombudsman may grant a request for review of a scientific dispute by this Panel.

3. Guidance for Industry: A Suggested Approach to Resolving Least Burdensome

This guidance document, published in 2000, suggests ways to resolve certain "least burdensome" issues, including contacting the CDRH Ombudsman to facilitate a resolution.