[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: 21CFR808.85]

[Page 89]
 
                        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. 808.85  Ohio.

    (a) The following Ohio 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: Ohio Revised Code, section 4747.09, the first two sentences 
with respect to disclosure of information to purchasers on the condition 
that, in enforcing these requirements, Ohio apply the definition of 
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Ohio 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: 
Ohio Revised Code, section 4747.09, the last two sentences with respect 
to medical examination of children.

[45 FR 67337, Oct. 10, 1980]