New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS
Section 16.19.14.9 - ADULTERATION
Universal Citation: 16 NM Admin Code 16.19.14.9
Current through Register Vol. 35, No. 18, September 24, 2024
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.
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