CFR

808.80—New Jersey.

(a) The following New Jersey medical device requirements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act:

(1) New Jersey Statutes Annotated, section 45:9A-23 on the condition that, in enforcing this requirement, New Jersey apply the definition of “used hearing aid” in § 801.420(a)(6) of this chapter ;

(2) New Jersey Statutes Annotated, sections 45:9A-24 and 45:9A-25 ;

(3) Chapter 3, Section 5 of the Rules and Regulations adopted pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. except as provided in paragraph (b) of this section.

(b) The following New Jersey medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Chapter 3, Section 5 of the Rules and Regulations adopted pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. to the extent that it requires testing to be conducted in an environment which meets or exceeds the American National Standards Institute S3.1 Standard.

Code of Federal Regulations

[45 FR 67337, Oct. 10, 1980]

Tips