Section 6146 - Liquid Chemical Sterilants(a) For purposes of this section, a "critical medical device" is any device that is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, and a "semicritical medical device" is any device that contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.(b) Manufacturers of, importers of, and dealers in liquid chemical sterilant products (including any such products with subordinate disinfectant claims) intended for use on critical or semicritical medical devices (as device is defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. sec. 321), are exempt from the requirements of Division 7 of the Food and Agricultural Code, providing the following criteria are met: (1) The product is not included in the federal definition of a pesticide under subdivision (u) of section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. sec. 136(u)] .(2) The product has premarket clearance from the Federal Food and Drug Administration under section 510(k) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. sec. 360(k)] .(3) The product does not include ethylene oxide as an active ingredient.(c) Whenever the manufacturer of, importer of, or dealer in any exempted liquid chemical sterilant has factual or scientific information of any adverse effect or risk to human health or the environment that has not previously been submitted to the department, the manufacturer, importer, or dealer shall report the information to the department within 60 days of learning of the information.(d) Physicians, surgeons, and local health officers remain subject to the illness reporting requirements of Health and Safety Code section 105200 with regard to exempted liquid chemical sterilants.Cal. Code Regs. Tit. 3, § 6146
1. New section filed 3-9-98 as an emergency; operative 3-9-98 (Register 98, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-7-98 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 3-9-98 order, including amendment of subsections (a), (b)(1) and (b)(2) and new subsection (e), transmitted to OAL 7-1-98 and filed 8-12-98 (Register 98, No. 33).
3. Repealer of subsection (e) filed 1-20-2000; operative 2-19-2000 (Register 2000, No. 3). Note: Authority cited: Section 12804, Food and Agricultural Code. Reference: Section 12804, Food and Agricultural Code.
1. New section filed 3-9-98 as an emergency; operative 3-9-98 (Register 98, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-7-98 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 3-9-98 order, including amendment of subsections (a), (b)(1) and (b)(2) and new subsection (e), transmitted to OAL 7-1-98 and filed 8-12-98 (Register 98, No. 33).
3. Repealer of subsection (e) filed 1-20-2000; operative 2-19-2000 (Register 2000, No. 3).