Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.603 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
The following words and terms, when used in these sections,
					 shall have the following meanings, unless the context clearly indicates
					 otherwise.
(1) Act--The Texas Food,
				  Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter
				  432.
(2) Adulterated device--Has
				  the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and
				  Safety Code, Chapter 431, §431.111.
(3) Authorized agent--an employee of the
				  department who is designated by the commissioner to enforce the provisions of
				  this chapter.
(4) Change of
				  ownership--A sole proprietor who transfers all or part of the salvage
				  establishment or salvage broker business to another person or persons; the
				  removal, addition, or substitution of a person or persons as a partner in a
				  salvage establishment or salvage broker business owned by a partnership; a
				  corporate sale, transfer; reorganization; or merger of the corporation which
				  owns the salvage establishment or salvage broker business if the sale,
				  transfer, reorganization, or merger causes a change in the salvage
				  establishment's or salvage broker business's ownership to another person or
				  persons; or if any other type of association, the removal, addition, or
				  substitution of a person or persons as a principal of such
				  association.
(5) Class I exempt
				  device--A class I device not labeled or otherwise represented as sterile that
				  has been determined by the U.S. Food and Drug Administration to be exempt from
				  the current good manufacturing practice requirements in 21 CFR, Part 820
				  (quality system regulation), except for general requirements concerning records
				  (21 CFR,
				  §820.180) and complaint files
				  (21 CFR,
				  §820.198).
(6) Class I device--A device determined by
				  the U.S. Food and Drug Administration under the Federal Food, Drug, and
				  Cosmetic Act, §513, to be subject to only the general controls authorized
				  by or under §§501 (adulteration), 502 (misbranding), 510
				  (registration), 516 (banned devices), 518 (notification and other remedies),
				  519 (records and reports), and 520 (general provisions) of the Federal Food,
				  Drug, and Cosmetic Act.
(7) Class
				  II device--A device determined by the U.S. Food and Drug Administration under
				  the Federal Food, Drug, and Cosmetic Act, §513, to be subject to or
				  eventually subject to special controls, such as performance standards,
				  postmarket surveillance, patient registries, or guidance documents.
(8) Class III device--A device determined by
				  the U.S. Food and Drug Administration under the Federal Food, Drug, and
				  Cosmetic Act, §513, to be subject to or eventually subject to the
				  premarket approval requirements in the Federal Food, Drug, and Cosmetic Act,
				  §515.
(9) Commissioner--The
				  Commissioner of Health or his successor.
(10) Cosmetic--Any article or substance
				  intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or
				  otherwise applied to the human body for cleansing, beautifying, promoting
				  attractiveness, or altering appearances; or an article or substance for use as
				  a component of such an article, except that the term does not include
				  soap.
(11) Department--The
				  Department of State Health Services.
(12) Device--An instrument, apparatus,
				  implement, machine, contrivance, implant, in vitro reagent, or other similar or
				  related article, including any component; part, or accessory; that is:
(A) recognized in the official United States
				  Pharmacopoeia National Formulary or any supplement to it;
(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
(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.