[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.61]

[Page 80]
 
                        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. 808.61  Hawaii.

    (a) The following Hawaii 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: Hawaii Revised Statutes, chapter 451A, Sec. 14.1, subsection 
(a) with respect to medical examination of a child 10 years of age or 
under, and subsection (c).
    (b) The following Hawaii medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them exemption from preemption: Hawaii Revised Statutes, chapter 
451A, Sec. 14.1, subsection (a) to the extent that it requires a written 
authorization by a physician and does not allow adults to waive this 
requirement for personal, as well as religious reasons, and subsection 
(b).

[50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985]