[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.82]

[Page 82]
 
                        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. 808.82  New York.

    (a) The following New York 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) General Business Law, Article 37, sections 784(3) and (4).
    (2) Official Compilation of Codes, Rules and Regulations of the 
State of New York, Chapter V, Title 19, Subchapter G, section 191.10 and 
section 191.11(a) on the condition that, in enforcing these 
requirements, New York apply the definition of ``used hearing aid'' in 
Sec. 801.420(a)(6) of this chapter and section 191.11(b), (c), (d), and 
(e).
    (b) The following New York medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemptions from preemption under section 521(b) of the 
act:
    (1) General Business Law, Article 37, section 784.1.
    (2) Official Compilation of Codes, Rules and Regulations of the 
State of New York, Chapter V, Title 19, Subchapter G, sections 191.6, 
191.7, 191.8, and 191.9.

[45 FR 67337, Oct. 10, 1980]