FDA Seeks Comments on Assessment of the Device Review Process

December 19, 2012—The US Food and Drug Administration (FDA) announced in the Federal Register that it is accepting public comments on the “statement of work” for an assessment of the review process for medical device submissions. The assessment is part of the FDA's performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 through 2017. The assessment is described in Section V, “Independent Assessment of Review Process Management,” of the commitment letter entitled, “MDUFA Performance Goals and Procedure.”

The FDA advised that an independent contractor will conduct the assessment in two phases. The FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment.

Electronic or written comments must be submitted by February 4, 2013, either electronically at www.regulations.gov or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number “FDA-2012-N-1202.”

As summarized in the FDA's Federal Register notice, the assessment will address the FDA's premarket review process, using an assessment framework that draws from appropriate quality-system standards, including, but not limited to, management responsibility, document controls and records management, and corrective and preventive action.

According to the FDA's notice, the assessment will include, but not be limited to, the following areas: 

 1. Identification of process improvements and best practices for conducting predictable, efficient, and consistent premarket reviews that meet regulatory review standards. 

 2. Analysis of elements of the review process—including the presubmission process, and investigational device exemption, 510(k) premarket notification, and premarket approval application reviews. 

 3. Assessment of FDA methods and controls for collecting and reporting information on premarket review process resource use and performance. 

 4. Assessment of effectiveness of the FDA's Reviewer Training Program implementation. 

 5. Recommendations for ongoing periodic assessments and any additional, more detailed, or focused assessments.

The FDA stated that the agency will incorporate findings and recommendations, as appropriate, into its management of the premarket review program. The FDA will analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and ensure its effectiveness. The FDA will also incorporate the results of the assessment into a Good Review Management Practices guidance document. Implementation of this guidance document will include initial and ongoing training of FDA staff and periodic audits of compliance with the guidance.

Further background and details are available in the FDA's notification in the Federal Register.