New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS
Section 16.19.14.12 - CUSTOM DEVICES
Current through Register Vol. 35, No. 18, September 24, 2024
A. A custom device is one which is sometimes ordered from manufacturers by practitioners to conform to their own special needs or to those of their patients (i.e. prosthetic devices, dental devices and specially designed orthopedic footwear).
B. Custom devices are exempt from performance standards or pre-market approval requirements; however, they are subject to FDA requirements for investigational use, banning, restriction of distribution, adulteration and misbranding.
C. The exemption applied only to devices which are not generally available in finished form for dispensing, or on prescription, or for commercial distribution or generally available to other practitioners.
