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Regulatory Affairs

  • Safety, effectiveness, and quality are the watchwords of the medical device industry, and companies commit time and expertise to ensure that their devices perform properly and serve patient needs. This commitment starts at the earliest design phase and continues through the development, manufacturing, and distribution of a device.

  • 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.  

  • After the FDA conducts its premarket review of a medical device, the manufacture and performance of the device are tightly controlled and monitored through a series of postmarket requirements. FDA’s postmarket requirements encompass every aspect of a device’s manufacture – from production and processing to packaging, distribution and use.

  • The subjects below relate to premarket, postmarket, and quality topics. They are dynamic and closely watched by regulators, industry, and other stakeholders. We engage on these subjects through written submissions, in‑person discussions, and other communication channels.

  • Ethylene Oxide (EtO) gas is the most common way to sterilize medical devices, a process which is critical for preventing infections and ensuring patients have safe surgeries and medical treatments.

  • Proper servicing of complex, life-saving and life-sustaining medical devices is vital to their safe and effective functioning and the safety of patients and device users.