N.M. Admin. Code § 16.19.14.10

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.14.10 - MISBRANDING

A device may be deemed to be misbranded if:

A. Manufactured in a nonregistered establishment pursuant to federal requirements.

B. If advertising and description literature fails to meet minimum requirements for disclosure of product information.

C. Devices subject to performance standards set by FDA, whose labeling fails to meet those prescribed in the standard.

D. Devices that fail or whose manufacturer refuses to comply with requirements relating to notification and other remedies and requirements or fails to maintain adequate records and necessary reports as required under the federal act Section 518-519.

E. If its label does not bear adequate directions for use and adequate warning against unsafe use.

F. If the labeling is false or misleading.

G. If it is a restricted device and fails to bear required labeling.

N.M. Admin. Code § 16.19.14.10

03-07-80...08-27-90; 16.19.14.10 NMAC - Rn, 16 NMAC 19.14.10, 03-30-02, Adopted by New Mexico Register, Volume XXXIV, Issue 04, February 28, 2023, eff. 2/28/2023