[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.1]

[Page 74-76]
 
                        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. 808.1  Scope.


    (a) This part prescribes procedures for the submission, review, and 
approval of applications for exemption from Federal preemption of State 
and local requirements applicable to medical devices under section 521 
of the act.
    (b) Section 521(a) of the act contains special provisions governing 
the regulation of devices by States and localities. That section 
prescribes a general rule that after May 28, 1976, no State or political 
subdivision of a State may establish or continue in effect any 
requirement with respect to a medical device intended for human use 
having the force and effect of law (whether established by statute, 
ordinance, regulation, or court decision), which is different from, or 
in addition to, any requirement applicable to such device under any 
provision of the act and which relates to the safety or effectiveness of 
the device or to any other matter included in a requirement applicable 
to the device under the act.
    (c) Section 521(b) of the act contains a provision whereby the 
Commissioner of Food and Drugs may, upon application by a State or 
political subdivision, allow imposition of a requirement which is 
different from, or in addition to, any requirement applicable under the 
act to the device (and which is thereby preempted) by promulgating a 
regulation in accordance with this part exempting the State or local 
requirement from preemption. The granting of an exemption does not 
affect the applicability to the device of any requirements under the 
act. The Commissioner may promulgate an exemption regulation for the 
preempted requirement if he makes either of the following findings:
    (1) That the requirement is more stringent than a requirement under 
the act applicable to the device; or
    (2) That the requirement is required by compelling local conditions 
and

[[Page 75]]

compliance with the requirement would not cause the device to be in 
violation of any applicable requirement under the act.
    (d) State or local requirements are preempted only when the Food and 
Drug Administration has established specific counterpart regulations or 
there are other specific requirements applicable to a particular device 
under the act, thereby making any existing divergent State or local 
requirements applicable to the device different from, or in addition to, 
the specific Food and Drug Administration requirements. There are other 
State or local requirements that affect devices that are not preempted 
by section 521(a) of the act because they are not ``requirements 
applicable to a device'' within the meaning of section 521(a) of the 
act. The following are examples of State or local requirements that are 
not regarded as preempted by section 521 of the act:
    (1) Section 521(a) does not preempt State or local requirements of 
general applicability where the purpose of the requirement relates 
either to other products in addition to devices (e.g., requirements such 
as general electrical codes, and the Uniform Commercial Code (warranty 
of fitness)), or to unfair trade practices in which the requirements are 
not limited to devices.
    (2) Section 521(a) does not preempt State or local requirements that 
are equal to, or substantially identical to, requirements imposed by or 
under the act.
    (3) Section 521(a) does not preempt State or local permits, 
licensing, registration, certification, or other requirements relating 
to the approval or sanction of the practice of medicine, dentistry, 
optometry, pharmacy, nursing, podiatry, or any other of the healing arts 
or allied medical sciences or related professions or occupations that 
administer, dispense, or sell devices. However, regulations issued under 
section 520(e) or (g) of the act may impose restrictions on the sale, 
distribution, or use of a device beyond those prescribed in State or 
local requirements. If there is a conflict between such restrictions and 
State or local requirements, the Federal regulations shall prevail.
    (4) Section 521(a) does not preempt specifications in contracts 
entered into by States or localities for procurement of devices.
    (5) Section 521(a) does not preempt criteria for payment of State or 
local obligations under Medicaid and similar Federal, State or local 
health-care programs.
    (6)(i) Section 521(a) does not preempt State or local requirements 
respecting general enforcement, e.g., requirements that State inspection 
be permitted of factory records concerning all devices, registration, 
and licensing requirements for manufacturers and others, and prohibition 
of manufacture of devices in unlicensed establishments. However, Federal 
regulations issued under sections 519 and 520(f) of the act may impose 
requirements for records and reports and good manufacturing practices 
beyond those prescribed in State or local requirements. If there is a 
conflict between such regulations and State or local requirements, the 
Federal regulations shall prevail.
    (ii) Generally, section 521(a) does not preempt a State or local 
requirement prohibiting the manufacture of adulterated or misbranded 
devices. Where, however, such a prohibition has the effect of 
establishing a substantive requirement for a specific device, e.g., a 
specific labeling requirement, then the prohibition will be preempted if 
the requirement is different from, or in addition to, a Federal 
requirement established under the act. In determining whether such a 
requirement is preempted, the determinative factor is how the 
requirement is interpreted and enforced by the State or local government 
and not the literal language of the statute, which may be identical to a 
provision in the act.
    (7) Section 521(a) does not preempt State or local provisions 
respecting delegations of authority and related administrative matters 
relating to devices.
    (8) Section 521(a) does not preempt a State or local requirement 
whose sole purpose is raising revenue or charging fees for services, 
registration, or regulatory programs.
    (9) Section 521(a) does not preempt State or local requirements of 
the

[[Page 76]]

types that have been developed under the Atomic Energy act of 1954 (42 
U.S.C. 2011 note), as amended, the Radiation Control for Health and 
Safety Act of 1968 (Pub. L. 90-602 (42 U.S.C. 263b et seq.)) and other 
Federal statutes, until such time as the Food and Drug Administration 
issues specific requirements under the Federal Food, Drug, and Cosmetic 
Act applicable to these types of devices.
    (10) Part 820 of this chapter (21 CFR part 820) (CGMP requirements) 
does not preempt remedies created by States or Territories of the United 
States, the District of Columbia, or the Commonwealth of Puerto Rico.
    (e) It is the responsibility of the Food and Drug Administration, 
subject to review by Federal courts, to determine whether a State or 
local requirement is equal to, or substantially identical to, 
requirements imposed by or under the act, or is different from, or in 
addition to, such requirements, in accordance with the procedures 
provided by this part. However, it is the responsibility of States and 
political subdivisions to determine initially whether to seek exemptions 
from preemption. Any State or political subdivision whose requirements 
relating to devices are preempted by section 521(a) may petition the 
Commissioner of Food and Drugs for exemption from preemption, in 
accordance with the procedures provided by this part.
    (f) The Federal requirement with respect to a device applies whether 
or not a corresponding State or local requirement is preempted or 
exempted from preemption. As a result, if a State or local requirement 
that the Food and Drug Administration has exempted from preemption is 
not as broad in its application as the Federal requirement, the Federal 
requirement applies to all circumstances not covered by the State or 
local requirement.

[43 FR 18665, May 2, 1978, as amended at 45 FR 67336, Oct. 10, 1980; 61 
FR 52654, Oct. 7, 1996]