[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.55]

[Page 86]
 
                        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. 808.55  California.

    (a) The following California medical device requirements are 
enforceable notwithstanding section 521 of the act because the Food and 
Drug Administration exempted them from preemption under section 521(b) 
of the act: Business and Professions Code sections 3365 and 3365.6.
    (b) The following California medical device requirements are 
preempted by section 521 of the act, and FDA has denied them an 
exemption from preemption:
    (1) Sherman Food, Drug, and Cosmetic Law (Division 21 of the 
California Health and Safety Code), sections 26207, 26607, 26614, 26615, 
26618, 26631, 26640, and 26641, to the extent that they apply to 
devices.
    (2) Sherman Food, Drug, and Cosmetic Law, section 26463(m) to the 
extent that it applies to hearing aids.
    (3) Business and Professions Code section 2541.3, to the extent that 
it requires adoption of American National Standards Institute standards 
Z-80.1 and Z-80.2.

[45 FR 67324, Oct. 10, 1980]

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