The following words and terms, when used in these sections, have the following meanings, unless the context clearly indicates otherwise.

1. (1) Act--The Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code (HSC) Chapter 431.
2. (2) Adulterated Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, HSC §431.111.
3. (3) Advertising--All representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.
4. (4) Authorized agent--An employee of the department who is designated by the commissioner to enforce the provisions of this chapter.
5. (5) Commissioner--The commissioner of the Department of State Health Services, or the commissioner's successor or designee.
6. (6) Counterfeit device--A device which, or the container, packaging or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.
7. (7) Department--The Department of State Health Services.

8. (8) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:

   1. (A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;
   2. (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or
   3. (C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes. The term "device" does not include software functions excluded by the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360j.
9. (9) Distributor--A person who furthers the marketing of a finished domestic or imported device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user. The term includes an importer or an own-label distributor. The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labeling of the finished device or the finished device package.
10. (10) Electronic product radiation--Any ionizing or nonionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
11. (11) Finished device--A device, or any accessory to a device, that is suitable for use, whether or not packaged or labeled for commercial distribution.
12. (12) Health authority--A physician designated to administer state and local laws relating to public health.
13. (13) Importer--Any person who initially distributes a device imported into the United States.
14. (14) Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles.

15. (15) Labeling--All labels and other written, printed, or graphic matter:

    1. (A) upon any article or any of its containers or wrappers; or
    2. (B) accompanying such article.

16. (16) Manufacture--The making by chemical, physical, biological, or other procedures of any article that meets the definition of device. The term includes the following activities:

    1. (A) repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;
    2. (B) initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications; or
    3. (C) sterilization, including contract sterilization services of a device for another establishment's devices.
17. (17) Manufacturer--A person who manufactures, fabricates, assembles, or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device.
18. (18) Misbranded Device--Has the meaning specified in the Texas Food, Drug, and Cosmetic Act, HSC §431.112.
19. (19) Person--Includes individual, partnership, corporation, and association.
20. (20) Place of business--Each location at which a device is manufactured or held for distribution.
21. (21) Practitioner--As defined in HSC §483.001(12).
22. (22) Prescription device--A restricted device that, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which adequate directions for use cannot be prepared.
23. (23) Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.
24. (24) Radioactive material--Any material (solid, liquid, or gas) that emits radiation spontaneously.
25. (25) Reconditioning--Any appropriate process or procedure by which distressed merchandise can be brought into compliance with departmental standards as specified in the Texas Food, Drug, Device, and Cosmetic Salvage Act, HSC §432.003, as defined in the rules in §229.603 of this chapter (relating to Definitions).
26. (26) Restricted device--A device subject to certain controls related to sale, distribution, or use as specified in the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360j.

Source Note:The provisions of this §229.433 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 January 1, 2005, 29 TexReg 11983; amended to be effective January 5, 2026, 51 TexReg 147.