Laws and Rules - Medical Device Manufacturers and Distributors

Texas Laws

• Texas Health and Safety Code - Chapter 431, Texas Food, Drug, and Cosmetic Act

Rules and Regulations

Texas Administrative Code, Title 25

• Sections 229.431 – 229.444, Licensing of Device Distributors and Manufacturers (HTML)
• Sections 229.431 – 229.444, Licensing of Device Distributors and Manufacturers (PDF, 89KB)
• Section 229.261, Assessment of Administrative or Civil Penalties

Code of Federal Regulations, Title 21

• Subchapter J, Radiological Health
• Part 801, Labeling
• Part 803, Medical Device Reporting
• Part 807, Establishment Registration & Device Listing for Manufacturers & Initial Importers of Devices
• Part 814, Premarket Approval of Medical Devices
• Part 820, Quality System Regulation