[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: 21CFR808.20]

                        TITLE 21--FOOD AND DRUGS
 
               CHAPTER I--FOOD AND DRUG ADMINISTRATION
               DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS

Subpart B--Exemption Procedures
 
Sec. 808.20 Application.


    (a) Any State or political subdivision may apply to the Food and 
Drug Administration for an exemption from preemption for any requirement 
that it has enacted and that is preempted. An exemption may only be 
granted for a requirement that has been enacted, promulgated, or issued 
in final form by the authorized body or official of the State or 
political subdivision so as to have the force and effect of law. 
However, an application for exemption may be submitted before the 
effective date of the requirement.
    (b) An application for exemption shall be in the form of a letter to 
the Commissioner of Food and Drugs and shall be signed by an individual 
who is authorized to request the exemption on behalf of the State or 
political subdivision. An original and two copies of the letter and any 
accompanying material, as well as any subsequent reports or 
correspondence concerning an application, shall be submitted to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr. Rockville, MD 20857. The outside wrapper of any 
application, report, or correspondence should indicate that it concerns 
an application for exemption from preemption of device requirements.
    (c) For each requirement for which an exemption is sought, the 
application shall include the following information to the fullest 
extent possible, or an explanation of why such information has not been 
included:
    (1) Identification and a current copy of any statute, rule, 
regulation, or ordinance of the State or political subdivision 
considered by the State or political subdivision to be a requirement 
which is preempted, with a reference to the date of enactment, 
promulgation, or issuance in final form. The application shall also 
include, where available, copies of any legislative history or 
background materials pertinent to enactment, promulgation, or issuance 
of the requirement, including hearing reports or studies concerning 
development or consideration of the requirement. If the requirement has 
been subject to any judicial or administrative interpretations, the 
State or political subdivision shall furnish copies of such judicial or 
administrative interpretations.
    (2) A comparison of the requirement of the State or political 
subdivision and any applicable Federal requirements to show similarities 
and differences.
    (3) Information on the nature of the problem addressed by the 
requirement of the State or political subdivision.
    (4) Identification of which (or both) of the following bases is 
relied upon for seeking an exemption from preemption:
    (i) The requirement is more stringent than a requirement applicable 
to a device under the act. If the State or political subdivision relies 
upon this
basis for exemption from preemption, the application shall include 
information, data, or material showing how and why the requirement of 
the State or political subdivision is more stringent than requirements 
under the act.
    (ii) The requirement is required by compelling local conditions, and 
compliance with the requirement would not cause the device to be in 
violation of any applicable requirement under the act. If the State or 
political subdivision relies upon this basis for exemption from 
preemption, the application shall include information, data, or material 
showing why compliance with the requirement of the State or political 
subdivision would not cause a device to be in violation of any 
applicable requirement under the act and why the requirement is required 
by compelling local conditions. The application shall also explain in 
detail the compelling local conditions that justify the requirement.
    (5) The title of the chief administrative or legal officers of that 
State or local agency that has primary responsibility for administration 
of the requirement.
    (6) When requested by the Food and Drug Administration, any records 
concerning administration of any requirement which is the subject of an 
exemption or an application for an exemption from preemption.
    (7) Information on how the public health may be benefitted and how 
interstate commerce may be affected, if an exemption is granted.
    (8) Any other pertinent information respecting the requirement 
voluntarily submitted by the applicant.
    (d) If litigation regarding applicability of the requirement is 
pending, the State or political subdivision may so indicate in its 
application and request expedited action on such application.

[43 FR 18665, May 2, 1978; 43 FR 22010, May 23, 1978, as amended at 49 
FR 3646, Jan. 30, 1984; 59 FR 14365, Mar. 28, 1994]