New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS
Section 16.19.14.11 - RESTRICTED DEVICE (PRESCRIPTION STATUS)
Universal Citation: 16 NM Admin Code 16.19.14.11
Current through Register Vol. 35, No. 18, September 24, 2024
A. FDA requirements may restrict the sale, distribution, or use of a device if there cannot be reasonable assurance of its safety and effectiveness.
B. Prescription status devices are determined on the basis of its intended use and whether or not the device can be adequately labeled as usable by the layman (i.e., pacemaker, hearing aids, hear valves, etc.).
C. Labeling must contain certain information such as name of device, statement of intended use, relevant warnings, precaution, side effects and contraindications.
D. Labeling of a restricted device, other than surgical instruments, shall bear:
(1)
"CAUTION: Federal law restricts this device to sale by or on the order of a
______:, physician, dentist, veterinarian, or with the descriptive designation
of any other practitioner licensed by the laws of this State to prescribe or
use the device in his practice.
(2)
The method of its application or use.
(3) The label meets all other requirements
under CFR Title 21, Section 801.109 (c) and (d) and (e).
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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