[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: 21CFR808.89]

[Page 82-83]
 
                        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. 808.89  Rhode Island.

    The following Rhode Island 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

[[Page 83]]

under section 521(b) of the act: Rhode Island General Laws, Section 5-
49-2.1, and Section 2.2, to the extent that Section 2.2 requires hearing 
aid dispensers to keep copies of the certificates of need.

[45 FR 67337, Oct. 10, 1980]