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Compliance In Focus
Posted by John Lehmann on Fri, Dec 21, 2012

How Would You Improve FDA’s Device Review Process?

How Would You Improve FDA’s Device Review Process?This is a question that FDA is asking the public. Recently on Federal Register, the FDA announced an opportunity for the public to comment as part of an assessment process of the medical device review/submissions.  This opportunity stems from the MDUFA Commitment Letter, where FDA has a section describing the assessment of review process management to meet certain performance goals agreed to by industry and FDA.

According to the press-release on Federal Register, the assessment will include an “analysis of elements of the review process that consume of save time to facilitate a more efficient process.” The review process is a general term and includes the presubmission process, and investigational device exemption, premarket notification (510(k)), and premarket approval application reviews. Included in the analysis would be an in-depth look into the root causes for inefficiencies as well as recommended actions.

In addition to the review process analysis, FDA is also asking for feedback in the following areas:

  • Identification of process improvements and best practices for conducting predictable, efficient, and consistent premarket reviews that meet regulatory review standards.
  • Assessment of FDA methods and controls for collecting and reporting information on premarket review process resource use and performance.
  • Assessment of effectiveness of FDA's Reviewer Training Program implementation.
  • Recommendations for ongoing periodic assessments and any additional, more detailed or focused assessments.

With the comments and recommendations FDA receives, the goal is for the findings to be incorporated into FDA’s management of the premarket review program. If you would like to submit your assessment of FDA’s device review process, you can submit electronic comments to: http://www.regulations.gov.

Please feel free to comment below and let us know what your assessment would entail.

Photo Credit: StreetFly JZ

510(k) Current Status and Considerations 

Topics: Device Review Process, Federal Register, FDA, 510(k)


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