1. (a) Minimum requirements. All device distributors or manufacturers 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, HSC Chapter 431 (Act). For the purpose of this section, the department adopts the policies described in the United States Food and Drug Administration's (FDA's) Compliance Policy Guides relating to devices.
2. (b) Federal establishment registration and device listing. All persons who operate as device distributors or manufacturers in Texas must meet the applicable requirements in 21 Code of Federal Regulations (CFR) Part 807, relating to Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Devices distributed by device distributors or manufacturers must have met, if applicable, the premarket notification requirements of 21 CFR Part 807 or the premarket approval provisions of 21 CFR Part 814, relating to 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 must comply with the applicable requirements of 21 CFR Part 820, relating to Quality Management System Regulation. The requirements in this part govern the methods, facilities, and controls used to design, manufacture, package, label, store, install, and service all finished devices intended for human use.

4. (d) Buildings and facilities.

   1. (1) Manufacturers must conduct all manufacturing, assembling, packaging, packing, holding, testing, or labeling of devices in buildings and facilities described in 21 CFR §820.45, relating to Device Labeling and Packaging Controls.
   2. (2) Manufacturers and distributors must not conduct any manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of devices in any personal residence or any room used as a living area. Manufacturers and distributors must not manufacture or hold devices in any room used as living or sleeping quarters. All device manufacturing and storage must be completely separated from any living or sleeping quarters by a full partition.

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

      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 designated quarantine area, physically separate from other devices, for storing outdated, damaged, deteriorated, misbranded, or adulterated devices until the quarantined devices are destroyed or returned to the supplier;
      4. (D) be maintained in a clean and orderly condition, including keeping walls, ceilings, windows, doors, and floors clean, in good repair, and properly maintained; 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 must be in-date, not damaged, and held at appropriate temperatures and in appropriate conditions under any labeling requirements of such devices.
6. (f) Device labeling. Devices distributed by device distributors or manufacturers must meet the labeling requirements of the Act and 21 CFR Part 801, relating to Labeling.
7. (g) Device labeling exemptions. Exemptions of labeling or packaging of devices adopted under the Federal Food, Drug, and Cosmetic Act must apply to devices in Texas, unless modified or rejected by rules of the executive commissioner of the Health and Human Services Commission.
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, HSC Chapter 432.
9. (i) Medical device reporting. Device distributors or manufacturers must meet the applicable medical device reporting requirements of 21 CFR Part 803, relating to Medical Device Reporting.
10. (j) Radiation emitting devices. Device distributors or manufacturers that distribute devices emitting electronic product radiation must meet the applicable requirements of the Act and 21 CFR Subchapter J, relating to Radiological Health.

11. (k) Distribution of prescription devices.

    1. (1) A prescription device in the possession of a device distributor or manufacturer licensed under these sections of this subchapter is exempt from HSC §431.112(e)(1), relating to labeling bearing adequate directions for use, providing it meets the requirements of 21 CFR §801.109, Prescription Devices, and §801.110, Retail Exemption for Prescription Devices.
    2. (2) Each device distributor or manufacturer who distributes prescription devices must maintain a record for every prescription device. The records kept must include the identity of the device, the quantity received or manufactured, and the disposition of each device.
    3. (3) Each device distributor or manufacturer who delivers a prescription device to the ultimate user must maintain a record of any prescription.

12. (l) Sale of contact lenses at flea markets. Contact lenses may not be sold by persons at flea markets unless:

    1. (1) the person selling the contact lenses has complied with the requirements of Texas Business and Commerce Code §35.55; and
    2. (2) the person selling the contact lenses has complied with the requirements of the Texas Occupations Code Chapter 353.
13. (m) Distribution of nonprescription devices. Records must include the identity of each device, the quantity received or manufactured, and the final disposition of each device.

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; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147.