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Regulatory Affairs

  • FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices. The 510(k) review process provides for the thorough FDA review of a wide range of products – from syringes to imaging systems – in a timely fashion that facilitates patient access to needed medical advancements.

  • Under the “Medical Device User Fee and Modernization Act of 2002” (MDUFMA), FDA was given the authority to collect user fees from medical device sponsors for review activities. Under the legislation, FDA committed to meeting specific performance goals negotiated between industry and the agency related to medical device reviews.

  • UDI consists of a unique code identifier that includes information specific for each device model as well as production data (lot or batch number, the serial number and/or expiration date), and an FDA-created database that will include a standard set of identifying elements for each UDI.

  • Like FDA, AdvaMed believes that product quality goes beyond compliance with current quality regulations. Instead, our goal is to partner with FDA to find design, production, and distribution practices that enhance medical device quality. We work towards this goal through efforts that include supporting FDA initiatives and by developing and providing resources and training on key principles of device quality.

  • CDRH advisory committees provide independent, professional advice from outside experts on the development, safety and effectiveness, and regulation of medical devices.  Going before an advisory committee can be a make-or-break moment for a device sponsor. Industry representatives (IRs) to these meetings play a critical role, helping to assure that these meetings focus on device safety and effectiveness and the issues under discussion.