SDOs exist for more than just medical devices, and they can be adopted by regulatory bodies. The International Standards Organization, one of the most widely known Standard Delivery Organization (SDO), creates standards that span industries. The FDA has adopted almost 600 medical device standards from ISO.

The Association for the Advancement of Medical Instrumentation (AAMI), International Electrotechnical Commission (IEC) and National Institute of Standards and Technology (NIST) are widely accepted SDOs in the US. While the International Medical Device Regulators Forum (IMDRF) doesn’t define itself as an SDO, it creates guidance documents that can be (and are often) treated as standards.

The Consumer Technology Association (CTA), which sponsors popular consumer technology trade show CES, is another up-and-coming SDO, Henry said.

CTA is also the only SDO that has published a final standard on health care AI, which it created in collaboration with the American National Standards Institute (ANSI).

Expert: Which AI Standard Is The Gold Standard?

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