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 229.604 - Exemptions and Applicability

Universal Citation: 25 TX Admin Code ยง 229.604

Current through Reg. 49, No. 38; September 20, 2024

(a) A person is exempt from licensing under these sections if the person is:

(1) a manufacturer or distributor of a device who in the normal course of business engages in the activities of reconditioning the device manufactured or distributed by or for that person and not purchased by that person solely for the purpose of reconditioning and sale;

(2) a person who is a common carrier or the common carrier's agent, who disposes of or otherwise transfers an undamaged or distressed device to a person who is exempt under this section or to a licensed salvage broker or salvage operator; or

(3) a person who transfers a distressed device to a licensed salvage broker or salvage operator.

(b) An exemption from the licensing requirements under these sections does not constitute an exemption from other applicable provisions of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 or the rules adopted to administer and enforce the Act.

(c) A salvage establishment or salvage broker who is engaging in conduct within the scope of the license issued under § 229.605 of this title (relating to Licensing Requirements and Procedures) is not required to also be licensed under Health and Safety Code, Chapter 431. An exemption from the licensing requirements under Health and Safety Code, Chapter 431, does not constitute an exemption from other applicable provisions of Health and Safety Code, Chapter 431, or the rules adopted to administer and enforce the chapter.

(d) These sections do not apply to the sale or distribution of previously used devices that are not distressed devices and have been determined to function properly and meet manufacturer's performance specifications. Acceptable determinations of functionality shall include at least one of the following:

(1) certification statements;

(2) reports of inspection, installation, or calibration; or

(3) product conformance affidavits.

(e) All certification statements, reports, and conformance affidavits referenced in subsection (d) of this section shall be completed, signed and dated no more than 14 days prior to the time of sale or distribution by:

(1) a qualified representative of the seller;

(2) a qualified representative of a hospital licensed under Health and Safety Code, Chapter 241;

(3) a person licensed under these sections; or

(4) a state or federal regulatory agency having knowledge or jurisdiction over the devices subject to any sale or distribution.

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