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Report (OEI-01-10-00470)

06-04-2012
Scientific Disagreements Regarding Medical Device Regulatory Decisions

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Summary

WHY WE DID THIS STUDY

FDA plays a critical role in ensuring the safety and effectiveness of medical devices and other products. At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions.

HOW WE DID THIS STUDY

We surveyed CDRH managers and reviewers, requesting that they identify scientific disagreements that occurred during the fiscal year 2008-2010 period. We then reviewed the administrative files related to 36 reported scientific disagreements for the same period. We also surveyed respondents about their awareness of and training on CDRH's new policies and procedures for addressing scientific disagreements.

WHAT WE FOUND

Of the 36 reported scientific disagreements, 3 occurred after October 2009, and the new procedures were used to resolve them. The nature and resolutions of these 36 disagreements varied widely. Scientific disagreements often involved multiple issues, and most of their resolutions did not lead directly to the approval or clearance of devices. Most administrative files related to scientific disagreements contained required documentation, although accountability for file completeness is unclear. In addition, not all of CDRH's managers and reviewers have received training on the new procedures. CDRH also faces broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion.

WHAT WE RECOMMEND

We recommend that FDA: (1) define more clearly its requirements for documenting and resolving scientific disagreements, (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and (3) more clearly assign accountability for the contents of the administrative files of all submissions. FDA concurred with our three recommendations.

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