[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: 21CFR808.101]

[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. 808.101  District of Columbia.

    (a) The following District of Columbia medical device requirements 
are enforceable, notwithstanding section 521 of the act, because the 
Food and Drug Administration has exempted them from preemption under 
section 521(b) of the act:
    (1) Act 2-79, section 5, to the extent that it requires an 
audiological evaluation for children under the age of 18.
    (2) Act 2-79, section 6, on the condition that in enforcing section 
6(a)(5), the District of Columbia apply the definition of ``used hearing 
aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following District of Columbia 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: Act 2-79, section 5, except as provided in paragraph 
(a) of this section.

[46 FR 59236, Dec. 4, 1981]