1. (a) The Texas Department of Health (department) adopts by reference the following laws and regulations:

   1. (1) Federal Food, Drug, and Cosmetic Act, 21 United States Code, et seq., as amended;
   2. (2) 21 Code of Federal Regulations (CFR), Part 801, Labeling, as amended;
   3. (3) 21 CFR, Part 803, Medical Device Reporting, as amended;
   4. (4) 21 CFR, Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, as amended;
   5. (5) 21 CFR, Part 814, Premarket Approval of Medical Devices, as amended;
   6. (6) 21 CFR, Part 820, Quality System Regulation, as amended; and
   7. (7) 21 CFR, Subchapter J--Radiological Health, as amended.
2. (b) Copies of these laws and regulations are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours.
3. (c) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable Texas and federal laws and regulations.

Source Note:The provisions of this §229.432 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196.