[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: 21CFR808.3]

[Page 76]
 
                        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 A--General Provisions
 
Sec. 808.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Compelling local conditions includes any factors, 
considerations, or circumstances prevailing in, or characteristic of, 
the geographic area or population of the State or political subdivision 
that justify exemption from preemption.
    (c) More stringent refers to a requirement of greater 
restrictiveness or one that is expected to afford to those who may be 
exposed to a risk of injury from a device a higher degree of protection 
than is afforded by a requirement applicable to the device under the 
act.
    (d) Political subdivision or locality means any lawfully established 
local governmental unit within a State which unit has the authority to 
establish or continue in effect any requirement having the force and 
effect of law with respect to a device intended for human use.
    (e) State means a State, American Samoa, the Canal Zone, the 
Commonwealth of Puerto Rico, the District of Columbia, Guam, Johnston 
Island, Kingman Reef, Midway Island, the Trust Territory of the Pacific 
Islands, the Virgin Islands, and Wake Island.
    (f) Substantially identical to refers to the fact that a State or 
local requirement does not significantly differ in effect from a Federal 
requirement.