25 TAC § 229.432. Applicable Laws and Regulations

(a) The department adopts by reference the following laws and regulations:

(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code, et seq., as amended;

(2) 21 Code of Federal Regulations (CFR), Part 801, Labeling, as amended;

(3) 21 CFR, Part 803, Medical Device Reporting, as amended;

(4) 21 CFR, Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, as amended;

(5) 21 CFR, Part 814, Premarket Approval of Medical Devices, as amended;

(6) 21 CFR, Part 820, Quality System Regulation, as amended; and

(7) 21 CFR, Subchapter J--Radiological Health, as amended.

(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 http://www.dshs.state.tx.us/license.shtm.

(c) Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable Texas and federal laws and regulations.