[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.88]

[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. 808.88  Pennsylvania.

    (a) The following Pennsylvania 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: 35 Purdon's Statutes 6700, section 504(4) on the 
condition that, in enforcing this requirement, Pennsylvania apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter; section 506; and, section 507(2).
    (b) The following Pennsylvania 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: 35 Purdon's Statutes 6700, section 402.

[45 FR 67326, Oct. 10, 1980]