N.M. Admin. Code § 16.19.14.11

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

Section 16.19.14.11 - RESTRICTED DEVICE (PRESCRIPTION STATUS)

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).

N.M. Admin. Code § 16.19.14.11

03-07-80...08-27-90; 16.19.14.11 NMAC - Rn, 16 NMAC 19.14.11, 03-30-02, Adopted by New Mexico Register, Volume XXXIV, Issue 04, February 28, 2023, eff. 2/28/2023