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Laws and Rules - Medical Device Manufacturers and Distributors
Laws and Rules - Medical Device Manufacturers and Distributors
Texas Laws
Texas Health and Safety Code - Chapter 431, Texas Food, Drug, and Cosmetic Act
Rules & 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
Last updated
May 14, 2020