If a device is identified as “Exempt” on the List of SUDs (Appendix A), is it exempt from both premarket and non-premarket requirements?
Answer. No. A “Y” (yes) in the column identified as “Exempt (Y/N)?” means that the device is exempt from the premarket requirements only. It does not provide any information on whether or not the device is exempt from any of the non-premarket regulatory requirements. A revised list that includes a column titled “Premarket Exempt” and another column titled “GMP Exempt” has been provided to clarify the types of exemptions that apply to a particular type of device. That list can be found on the Internet.
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