Daily Rules, Proposed Rules, and Notices of the Federal Government
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Post-approval studies (PAS) are imposed as conditions of approval for some class III devices regulated under premarket approval (PMA) regulations and are an important public health tool for developing additional evidence on device performance in the postmarket setting. In order for PAS to be most effective, studies must be well-designed, scientifically sound, meaningful and feasible, and must provide complete and timely information. PMA conditions of approval studies are constructed to ask for specific, detailed data in a subsequent PAS relating to unanswered questions in premarket data. However, there are often opportunities for leveraging the design and conduct of PAS, enhancing its utility to other important stakeholders. In addition to the direct role of PMA holders, the role of other public health partners is expanding, as evidenced by a number of efforts external to CDRH that are directly or indirectly involved in collecting and analyzing data relevant to estimating medical device use and risk and in communicating risk to target populations. To ensure a successful PAS program, CDRH, regulated industry, clinical researchers, and other stakeholders must remain well-informed and engaged in continuous dialogue regarding the design, implementation, reporting, and use of PAS and the resultant data. Further, it is the Center's desire to ensure this dialogue results in studies that maximize the public health impact by producing data that is informative to a range of stakeholders.
We intend to discuss a large number of issues at the workshop, including, but not limited to the following: (1) PAS within the Total Product Life Cycle, (2) best practices and improvement of PAS implementation strategies, (3) PAS impact on public health and medical device innovation, and (4) opportunities for innovative uses of PAS data.