The Morcellation “Debate” and the FDA 510(k) Process—A Call for Further Reform

Conclusions The current system currently transfers the responsibility of ensuring safety and efficacy to the public, patients, and providers. To minimize potential harm, the FDA needs to incorporate a greater standard of evidence into its framework for the approval and regulation of medical devices. The burden of these requirements should be borne at least in part by the companies bringing equipment to market. Relevance It is incumbent on all surgeons to be vigilant in their objective critical assessment of new instrumentation and report their outcomes after they come to market. Target Audience Obstetricians and gynecologists, family physicians Learning Objectives Physicians should be better able to: Identify the challenges associated with the current 510(k) process; Distinguish between the roles of the initial approval and postmarketing surveillance of surgical products and their safety; and Evaluate the efficacy of new surgical modalities and products.
Source: Obstetrical and Gynecological Survey - Category: OBGYN Tags: CME ARTICLES Source Type: research