[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: 21CFR808.71]

[Page 87-88]
 
                        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. 808.71  Massachusetts.

    (a) The following Massachusetts 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) Massachusetts General Laws, Chapter 93, Section 72, to the 
extent that it requires a hearing test evaluation for a child under the 
age of 18.
    (2) Massachusetts General Laws, Chapter 93, Section 74, except as 
provided in paragraph (6) of the Section, on the condition that, in 
enforcing this requirement, Massachusetts apply the definition of ``used 
hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Massachusetts medical device requirements are 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied them exemptions from preemption under section 
521(b) of the act.
    (1) Massachusetts General Laws, Chapter 93, Section 72, except as 
provided in paragraph (a) of this section.
    (2) Massachusetts General Laws, Chapter 93, Section 74, to the 
extent that it requires that the sales receipt

[[Page 88]]

contain a statement that State law requires a medical examination and a 
hearing test evaluation before the sale of a hearing aid.

[45 FR 67326, Oct. 10, 1980]