A device may be considered to be adulterated:

1. A. It is subject to a performance standard and does not comply with all requirements of such standard.
2. B. Class II device FDA pre-market approval is not completed.
3. C. It is a banned device.
4. D. It is in violation of good manufacturing practice requirements.
5. E. It fails to comply with the IDE (Investigational Device Exemption) protocol.

[16.19.14.9 NMAC – Rp, 16.19.14.9 NMAC, 2/28/2023]