[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: 21CFR808.35]

[Page 79]
 
                        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 B--Exemption Procedures
 
Sec. 808.35  Revocation of an exemption.

    (a) An exemption from preemption pursuant to a regulation under this 
part shall remain effective until the Commissioner revokes such 
exemption.
    (b) The Commissioner may by regulation, in accordance with 
Sec. 808.25, revoke an exemption from preemption for any of the 
following reasons:
    (1) An exemption may be revoked upon the effective date of a newly 
established requirement under the act which, in the Commissioner's view, 
addresses the objectives of an exempt requirement and which is 
described, when issued, as preempting a previously exempt State or local 
requirement.
    (2) An exemption may be revoked upon a finding that there has 
occurred a change in the bases listed in Sec. 808.20(c)(4) upon which 
the exemption was granted.
    (3) An exemption may be revoked if it is determined that a condition 
placed on the exemption by the regulation under which the exemption was 
granted has not been met or is no longer being met.
    (4) An exemption may be revoked if a State or local jurisdiction 
fails to submit records as provided in Sec. 808.20(c)(6).
    (5) An exemption may be revoked if a State or local jurisdiction to 
whom the exemption was originally granted requests revocation.
    (6) An exemption may be revoked if it is determined that it is no 
longer in the best interests of the public health to continue the 
exemption.
    (c) An exemption that has been revoked may be reinstated, upon 
request from the State or political subdivision, if the Commissioner, in 
accordance with the procedures in Sec. 808.25, determines that the 
grounds for revocation are no longer applicable except that the 
Commissioner may permit abbreviated submissions of the documents and 
materials normally required for an application for exemption under 
Sec. 808.20.