[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.69]

[Page 80]
 
                        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. 808.69  Maine.

    (a) The following Maine medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Maine Revised Statutes Annotated, Title 32, section 1658-C, on 
the condition that, in enforcing this requirement, Maine apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following Maine 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: 
Maine Revised Statutes Annotated, Title 32, section 1658-D and the last 
sentence of section 1658-E.

[45 FR 67336, Oct. 10, 1980]

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