Laws & Regulations - Medical Device Manufacturers and Distributors

Texas Laws 

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

Texas Administrative Code, Title 25 

• Sections 229.431 – 229.444, Licensing of Device Distributors and Manufacturers  

• Sections 229.431 – 229.444, Licensing of Device Distributors and Manufacturers  

• 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