Overview
Through the semester we viewed the 510(k) processes and ways they led into some of the problems highlighted in the “Bleeding Edge”. For this question, you will examine the PMA supplement process and suggest a means of improvement for better assurance of safety, effectiveness, and information for the public.
Many major device changes for Class 3 devices are approved by way of PMA supplements. FDA releases a summary of safety and effectiveness data (SSED) for only a small number of supplement approvals, and most are summarized with a one-sentence description of the device modification. FDA has the option of releasing summary review memos for supplement approvals, and initiated a pilot program :
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (fda.gov).
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Read the article by Rome, Kramer, and Kesselheim (2014) :
FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012 | Medical Devices and Equipment | JAMA | JAMA Network.
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In less than 500 words, describe the contents of Summary Review Memos from an example on the FDA website, and how this might improve the PMA supplement process with greater transparency of information available to the public and potentially improve a review quality issue raised by Rome et al. (2014).