N.M. Admin. Code § 16.19.14.9

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.14.9 - ADULTERATION

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.

N.M. Admin. Code § 16.19.14.9

03-07-80...08-27-90; 16.19.14.9 NMAC - Rn, 16 NMAC 19.14.9, 03-30-02, Adopted by New Mexico Register, Volume XXXIV, Issue 04, February 28, 2023, eff. 2/28/2023