[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.80]

[Page 88]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 808_EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL 
MEDICAL DEVICE REQUIREMENTS--Table of Contents
 
        Subpart C_Listing of Specific State and Local Exemptions
 
Sec. 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 Sec. 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.

[45 FR 67337, Oct. 10, 1980]