1. (a) The 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 Management 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 at the department, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at https://www.dshs.texas.gov.
3. (c) Nothing in these sections relieves 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; amended to be effective January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147.