Current through Reg. 49, No. 38; September 20, 2024
(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.
(1) A prescription device in the
possession of a salvage establishment or salvage broker licensed under these
sections of this subchapter is exempt from Health and Safety Code, §
431.112(f)(1),
relating to labeling bearing adequate directions for use, providing it meets
the requirements of
21 CFR,
§801.109 (prescription devices) and
21 CFR,
§801.110 (retail exemption for
prescription devices).
(2) Each
salvage establishment or salvage broker who sells or distributes a prescription
device shall establish and maintain a record for every prescription device,
showing the identity and quantity received, date of receipt, and the
disposition of each device.
(3)
Each salvage establishment or salvage broker who delivers a prescription device
to the ultimate user shall maintain a record of any prescription or other order
lawfully issued by a practitioner in connection with the device.
(q) Sale of contact lenses at flea
markets. Persons at flea markets may not sell contact lens devices unless:
(1) the person selling the contact lenses has
complied with the requirements of Business and Commerce Code, § 35.55;
and
(2) the person selling the
contact lenses has complied with the requirements of the Texas Contact Lens
Prescription Act, Texas Civil Statutes, Article 4552-A.
