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What are Class I and Class II medical device exemptions?

Are there any medical devices exempt from the 510(k) requirements?

  • A listing of Class I and Class II devices exempt from 510 (k) requirements is available on the Medical Device Exemptions 510 (k) and GMP Requirements website. General limitations to the exemptions are found in Title 21 of the Code of Federal Regulations (CFR) in sections 862.9 through 892.9.

Is there an application fee for Class I medical devices?

  • There is an application fee and an annual charge for Class I medical devices, which can be found at Fees and charges: summary from 1 July 2020.

How many Class I medical devices are on the FDA's list?

  • The FDA has compiled a list of over 70 class I medical devices that will no longer be subject to premarket notification requirements, effective immediately.

image-What are Class I and Class II medical device exemptions?
image-What are Class I and Class II medical device exemptions?
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