| (a) Salvageable devices. All salvageable devices shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid license to engage in a salvage operation or as provided for in subsection (o) of this section. (b) Reconditioned devices. All reconditioned devices must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431. (c) General labeling. All salvaged devices must be labeled in accordance with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §301 et seq., as amended; the Fair Packaging and Labeling Act, 15 U.S.C., §1451 et seq., as amended; and the federal regulations promulgated under those Acts. (d) Reconditioned Labeling. In addition to the general labeling requirements found in subsection (c) of this section, all reconditioned devices shall be labeled with the statement "Reconditioned by (name and business address of the salvage establishment responsible for the reconditioning of the device)." (e) Salvage warehouses. A person may not use a salvage warehouse to recondition devices or sell to consumers. (f) Personnel. Each salvage establishment that engages in the reconditioning of devices shall have sufficient personnel with the necessary education, background, training, and experience to assure that all reconditioning activities are correctly performed. With the exception of class I exempt devices, training of personnel engaged in the reconditioning of class I, II, or III devices shall be documented. (g) Operating procedures. Each salvage establishment that engages in the reconditioning of devices shall establish, maintain, and implement written procedures for identifying devices during all stages of receipt, reconditioning, distribution, and installation to prevent mixups. (h) Inspection, measuring, and test equipment. (1) Each salvage establishment that engages in the reconditioning of devices shall ensure that all inspection, measuring, and test equipment used in the reconditioning of devices is: (A) suitable for its intended purpose and capable of producing valid results; and (B) routinely calibrated, inspected, checked, and maintained. (2) Each salvage establishment that engages in the reconditioning of class II and III devices shall establish and maintain calibration records for inspection, measuring, and test equipment to include: (A) the equipment identification; (B) dates of calibration; (C) the person performing each calibration; and (D) the next scheduled calibration date. (i) Device history record. With the exception of class I exempt devices, each salvage establishment that engages in the reconditioning of class I, II, or III devices shall establish and maintain a device history record for each batch, lot, or unit reconditioned to ensure that devices are reconditioned in accordance with manufacturer's specifications. The device history record shall include the following information: (1) the dates of reconditioning; (2) the quantity reconditioned; (3) the quantity released for distribution; (4) the acceptance records which demonstrate the device is reconditioned in accordance with the device master record; (5) copies of any labeling required by these sections; and (6) any device identification or control number used. (j) Device master record. Each salvage establishment that engages in the reconditioning of class II or III devices shall establish and maintain device master records for each type of class II or III device reconditioned. The device master record shall include, or refer to the location of, the following information: (1) device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications; (2) reconditioning process specifications, including the appropriate equipment specifications, reconditioning methods, reconditioning procedures, and reconditioning environment specifications; (3) final acceptance procedures and specifications, including acceptance criteria and the inspection, measuring, and test equipment to be used; (4) packaging and labeling specifications, including methods and processes used; and (5) installation, maintenance, and servicing procedures and methods. (k) Complaint files. Each salvage establishment and salvage broker that engages in the reconditioning or distribution of distressed or salvaged devices shall establish and maintain complaint files. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated. All records of investigation shall include: (1) the name of the device; (2) the date the complaint was received; (3) any device identification(s) and control number(s) used; (4) the name, address, and phone number of the complainant; (5) whether the complaint is associated with any illness or injury involving the device; (6) the nature and details of the complaint; (7) the dates and results of the investigation; (8) any corrective action taken; (9) any reply to the complainant; and (10) the name and signature of the person formally designated by the salvage establishment or salvage broker as responsible for investigating all complaints. (l) Internal audits. Each salvage establishment that engages in the reconditioning of class II or III devices shall establish, maintain, and implement written procedures for conducting an internal quality audit and shall conduct such an audit at least annually. The dates and results of the audit shall be documented, including any deficiencies found and the corrective action taken to address the deficiencies. (m) Corrective and preventative action. Each salvage establishment that engages in the reconditioning of class II or III devices shall document any action taken by the salvage establishment to correct or prevent any nonconformities relating to a salvaged class II or III device or to the reconditioning of a class II or III device. (n) Device remanufacturers. Those salvage establishments who are also device remanufacturers shall comply with these sections and with the device manufacturer requirements in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, Subchapter L, including the applicable requirements in 21 CFR, Part 820 (quality system regulation). (o) Sale or distribution of unreconditioned devices. (1) A person licensed under §229.605(a) of this title (relating to Licensing Requirements and Procedures) who is unable to recondition a salvageable device in accordance with this chapter may sell or distribute the device if such device: (A) is sold or distributed to a person licensed under §229.605(a) of this title (relating to Licensing Requirements and Procedures); (B) is sold or distributed to a person located outside this state who is responsible for the reconditioning of the device prior to sale or distribution to the ultimate consumer located outside Texas. Each salvage establishment or salvage broker who sells or distributes a salvageable device to such a person shall maintain documentation that discloses the person is aware that the device requires reconditioning and that the person is authorized to perform such reconditioning under laws applicable to the state in which the person is located; or (C) is a non-prescription device to be used solely for a non-medical purpose (e.g. research, teaching, or analysis) and not introduced into commercial distribution for use on man or other animals, provided these conditions of sale or distribution are disclosed to the purchaser in writing. (2) At a minimum, all written disclosure records required in paragraph (1)(B)-(C) of this subsection shall: (A) include the information required by §229.612(a) of this title (relating to Records); (B) include a statement regarding the conditions of sale or distribution that is signed by both the seller and purchaser, and contains the address and telephone number of both the seller and purchaser; and (C) be retained as required in §229.612(b) of this title (relating to Records). (p) Sale or distribution of prescription devices. Cont'd... |
