Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.441 - Minimum Standards for Licensure

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Minimum requirements. All distributors or manufacturers of devices engaged in
				  the design, manufacture, packaging, labeling, storage, installation, and
				  servicing of devices must comply with the minimum standards of this section in
				  addition to the statutory requirements contained in the Texas Food, Drug, and
				  Cosmetic Act, Health and Safety Code, Chapter 431 (Act). For the purpose of
				  this section, the policies described in the United States Food and Drug
				  Administration's (FDA's) Compliance Policy Guides as they apply to devices
				  shall be the policies of the Department of State Health Services
				  (department).
(b) Federal
				  establishment registration and device listing. All persons who operate as
				  device distributors or manufacturers in Texas shall meet the applicable
				  requirements in 21 Code of Federal Regulations (CFR), Part 807, titled
				  "Establishment Registration and Device Listing for Manufacturers and Initial
				  Importers of Devices." Devices distributed by device distributors or
				  manufacturers shall have met, if applicable, the premarket notification
				  requirements of 21 CFR, Part 807 or the premarket approval provisions of 21
				  CFR, Part 814, titled "Premarket Approval of Medical Devices."
(c) Good manufacturing practices. Device
				  distributors or manufacturers engaged in the design, manufacture, packaging,
				  labeling, storage, installation, and servicing of finished devices shall be in
				  compliance with the applicable requirements of 21 CFR, Part 820, titled
				  "Quality System Regulation." The requirements in this part govern the methods
				  used in, and the facilities and controls used for, the design, manufacture,
				  packaging, labeling, storage, installation, and servicing of all finished
				  devices intended for human use.
(d)
				  Buildings and facilities.
(1) All
				  manufacturing, assembling, packaging, packing, holding, testing, or labeling of
				  devices by manufacturers shall take place in buildings and facilities described
				  in 21 CFR, Part 820, Subpart L, titled "Handling, Storage, Distribution, and
				  Installation."
(2) No
				  manufacturing, assembling, packaging, packing, holding, testing, or labeling
				  operations of devices by manufacturers or distributors shall be conducted in
				  any personal residence.
(3) Any
				  place of business used by a distributor to store, warehouse, hold, offer,
				  transport, or display devices shall:
(A) be
				  of suitable size and construction to facilitate cleaning, maintenance, and
				  proper operations;
(B) have storage
				  areas designed to provide adequate lighting, ventilation, temperature,
				  sanitation, humidity, and space;
(C) have a quarantine area for storage of
				  devices that are outdated, damaged, deteriorated, misbranded, or
				  adulterated;
(D) be maintained in a
				  clean and orderly condition; and
(E) be free from infestation by insects,
				  rodents, birds, or vermin of any kind.