1. (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 Texas Department of Health (department).
2. (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 Distributors 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."
3. (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.

4. (d) Buildings and facilities.

   1. (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. (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. (3) Any place of business used by a distributor to store, warehouse, hold, offer, transport, or display devices shall:

      1. (A) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
      2. (B) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;
      3. (C) have a quarantine area for storage of devices that are outdated, damaged, deteriorated, misbranded, or adulterated;
      4. (D) be maintained in a clean and orderly condition; and
      5. (E) be free from infestation by insects, rodents, birds, or vermin of any kind.
5. (e) Storage of devices. All devices stored by distributors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such devices.
6. (f) Device labeling. Devices distributed by device distributors or manufacturers shall meet the labeling requirements of the Act and 21 CFR, Part 801, titled "Labeling."
7. (g) Device labeling exemptions. Device labeling or packaging exemptions adopted under the Federal Food, Drug, and Cosmetic Act, as amended, shall apply to devices in Texas except insofar as modified or rejected by rules of the Texas Board of Health (board).
8. (h) Reconditioned devices. Reconditioned devices must comply with the provisions of the Act and these sections and are subject to the provisions of the Texas Food, Drug, Device and Cosmetic Salvage Act, Health and Safety Code, Chapter 432.
9. (i) Medical device reporting. Device distributors or manufacturers shall meet the applicable medical device reporting requirements of 21 CFR, Part 803, titled "Medical Device Reporting" or 21 CFR, Part 804, titled "Medical Device Distributor Reporting."
10. (j) Radiation emitting devices. Devices which emit electronic product radiation and are distributed by device distributors or manufacturers shall meet the applicable requirements of the Act and 21 CFR, Subchapter J, titled "Radiological Health."

Source Note:The provisions of this §229.441 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective March 19, 1996, 21 TexReg 1887; amended to be effective December 13, 1998, 23 TexReg 12353.