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 (PDF, 89KB)

Section:

• §229.431 - Purpose
• §229.432 - Applicable Laws and Regulations
• §229.433 - Definitions
• §229.434 - Exemptions
• §229.435 - Licensure Requirements
• §229.436 - Licensing Procedures
• §229.437 - Report of Changes
• §229.439 - Licensure Fees
• §229.440 - Refusal, Cancellation, Suspension, or Revocation of License
• §229.441 - Minimum Standards for Licensure
• §229.442 - Advertising
• §229.443 - Enforcement and Penalties
• §229.444 - Device Distributors and Manufacturers Advisory Committee

25 Texas Administrative Code (TAC), Subchapter P - Assessment of Administrative Penalties 

Section: 

• 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