[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: 21CFR808.98]

[Page 83]
 
                        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. 808.98  West Virginia.

    (a) The following West Virginia medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption: West Virginia 
Code, sections 30-26-14 (b) and (c) and section 30-26-15(a) on the 
condition that in enforcing section 30-26-15(a) West Virginia apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following West Virginia 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: West Virginia Code, section 30-26-14(a).

[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 35314, Sept. 13, 1988]