A device may be considered to be adulterated:
- A. It is subject to a performance standard and does not comply with all requirements of such standard.
- B. Class II device FDA pre-market approval is not completed.
- C. It is a banned device.
- D. It is in violation of good manufacturing practice requirements.
- 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]