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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.

  • Along with FDA, AdvaMed believes that product quality goes beyond compliance with the current Quality System Regulation (21 C.F.R. Part 820).  The Library of Successful Quality Practices stems from this belief, and was created by AdvaMed and its members to help medical technology quality professionals.  

  • The FDA’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) explores the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture.