[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: 21CFR808.97]

[Page 90]
 
                        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. 808.97  Washington.

    (a) The following Washington 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: Revised Code of Washington 18.35.110(2)(e) (i) and 
(iii) on the condition that it is enforced in addition to the applicable 
requirements of this chapter.
    (b) The following Washington medical device requirements are 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied them an exemption from preemption under 
section 521(b) of the act: Revised Code of Washington 
18.35.110(2)(e)(ii).

[45 FR 67337, Oct. 10, 1980]