Three regulatory classes are established based on the extent of control necessary to ensure safety and effectiveness of each device:

1. A. Class I -- General Controls

   1. (1) prohibiting adulteration or misbranding
   2. (2) requiring federal registration and listing by the manufacturer
   3. (3) requiring notification of risks, repairs, replacement or refund
   4. (4) requirement restricting sale, distribution or use
   5. (5) requirement with respect to good manufacturing practices, record keeping, reports and inspections
   6. (6) authority to ban the device

2. B. Class II -- Performance Standards

   1. (1) general controls not sufficient to assure safety and effectiveness
   2. (2) performance standards required by federal FDA
   3. (3) FDA regulations establishing the performance standard.

3. C. Class III -- Pre-Market Approval

   1. (1) represents life sustaining, life-supporting or implanted in the body or which presents a potential unreasonable risk of illness or injury.
   2. (2) requires investigational device exemption for research (IDE under federal act Sec. 520 (g)).

[16.19.14.8 NMAC – Rp, 16.19.14.8 NMAC, 2/28/2023]