N.M. Admin. Code § 16.19.14.12

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.14.12 - CUSTOM DEVICES

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.

N.M. Admin. Code § 16.19.14.12

03-07-80...08-27-90; 16.19.14.12 NMAC - Rn, 16 NMAC 19.14.12, 03-30-02, Adopted by New Mexico Register, Volume XXXIV, Issue 04, February 28, 2023, eff. 2/28/2023