§ 808.55 - California.  


Latest version.
  • § 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

    preempted under section 521(

    b

    a) 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

    Federal Food, Drug, and Cosmetic Act, and FDA has denied them

    an

    exemption from preemption:

    (

    1)

    a) Medical devices; general provisions. 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

    26441, 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)

    ; and

    (b) Ophthalmic devices; quality standards. California Business and Professions Code, section 2541.3

    ,

    to the extent that it requires adoption of the American National Standards Institute standards Z-80.1 and Z-80.2.

    [45 87 FR 6732450762, OctAug. 1017, 19802022]