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| The FDA believes that national and international device registries in selected product areas are the foundation of our National Medical Device Postmarket Surveillance System. |
by David R. Dills
Sr. Consultant, Regulatory & Compliance, Devices
NovusLife
A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention. Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians. A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition. This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.
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