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| In the United States, the federal Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) is responsible for regulating medical devices and radiation-emitting products. Many industry standards address aspects of safety and/or effectiveness relevant to medical devices. Many of these standards have been developed with the participation of CDRH staff.
The following are examples of organizations that develop industry standards that pertain to medical devices:
- Association for the Advancement of Medical Instrumentation (AAMI),
- Acoustical Society of America (ASA),
- ASTM International,
- Compressed Gas Association (CGA),
- National Electrical Manufacturers Association (NEMA), and
- Underwriters Laboratories, Inc. (UL)
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Field trips for this lesson:
- Search the FDA “Recognized Consensus Standards Database” to find standards for medical devices. Here are a few examples to get you started. Type "cardiac" in the Title field of the search screen, then hit the search button to see a list of reference standards. Try the search with other terms, such as "bone" and "dental."
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