New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS
Section 16.19.14.8 - CLASSIFICATION OF DEVICES
Universal Citation: 16 NM Admin Code 16.19.14.8
Current through Register Vol. 35, No. 18, September 24, 2024
Three regulatory classes are established based on the extent of control necessary to ensure safety and effectiveness of each device:
A. Class I -- General Controls
(1) prohibiting adulteration or
misbranding
(2) requiring federal
registration and listing by the manufacturer
(3) requiring notification of risks, repairs,
replacement or refund
(4)
requirement restricting sale, distribution or use
(5) requirement with respect to good
manufacturing practices, record keeping, reports and inspections
(6) authority to ban the device
B. Class II -- Performance Standards
(1) general controls not sufficient
to assure safety and effectiveness
(2) performance standards required by federal
FDA
(3) FDA regulations
establishing the performance standard.
C. Class III -- Pre-Market Approval
(1) represents life sustaining,
life-supporting or implanted in the body or which presents a potential
unreasonable risk of illness or injury.
(2) requires investigational device exemption
for research (IDE under federal act Sec. 520 (g)).
Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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