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AMP asks FDA to address barriers to device innovation
Date:6/25/2010

ive clinical specimens after the peak of the pandemic had passed.

Dr. Sobel identified a potential solution to the shortage of specimens, "The FDA should work to establish a biorepository of clinically relevant infectious agents, including strain variants and subtypes, to facilitate the rapid development and validation of assays for infectious agents, particularly those with pandemic potential." Alternatively, AMP also asked the FDA to consider establishing alternative validation strategies that are independent of primary clinical specimens, but are, nonetheless, rigorously grounded in sound science and infectious disease medicine.

Barrier 3. Test manufacturers perceive that there is an inconsistent and unclear regulatory pathway for their submissions. Manufacturers have faced uncertainty and/or inconsistency in the review of device submissions, in enforcement discretion, in device classification [510(k), 510(k) de novo, PMA, ASR, etc.], in requirements for acceptable analytical and clinical validations, and in requirements changing from the time of pre-IDE meetings through mid-trial. "IVD test manufacturers must then function within this uncertain regulatory environment, which makes it difficult to anticipate regulatory requirements and appropriately amend their business models," said Dr. Sobel.

To address the barriers identified above, AMP believes that the FDA can take several steps that would improve the regulatory process for molecular diagnostic tests without impinging upon an appropriate review to ensure that the public is protected.

  • FDA should ensure that policies and requirements are consistently applied, and that the scientific evidence and rationale for decisions are communicated effectively to diagnostic test manufacturers.
  • Communication from FDA to diagnostic test manufacturers should be as clear and as comprehensive as possible at the outset of the submission process. This will help manufacturers b
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Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

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