Texas Register, Volume 23, Number 31, Pages 7663-7938, July 31, 1998 Page: 7,706
7663-7938 p. ; 28 cm.View a full description of this periodical.
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product as the result of the operation of an electronic circuit in such
product.
(11) Finished device - A device, or any accessory to a
device, which is suitable for use, whether or not packaged or labeled
for commercial distribution.
(12) Health authority - A physician designated to admin-
ister state and local laws relating to public health.
(13) Importer - Any person who initially distributes a
device imported into the United States.
(14) Ionizing radiation - Any electromagnetic or particu-
late 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) Labeling - All labels and other written, printed, or
graphic matter:
(A) upon any article or any of its containers or
wrappers; or
(B) accompanying such article.
(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:
(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;
or
[B initial distrb ution of imported device er}
(B) [(C0)] initiation of specifications for devices that
are manufactured by a second party for subsequent commercial
distribution by the person initiating specifications.
(17) Manufacturer - A person who manufactures, fabri-
cates, assembles, or processes a finished device. The term includes a
person who repackages or relabels a finished device. The term does
not include[:]
[(A)] a person who only distributes a finished de-
vice.[;]
(B) the manufacture of raw materials or components
to be used in the manufacture or assembly of a device who would
otherwise not be required to license under the provisions of these
seetions9I
HG* the manufacture of general pup e article
such as chemical reagents or laboratory equipment whose uses are
generally known by persons trained in their use and which are not
labeled or promoted for medical uses;]
the manufature or otherwise altering of de-
avices by licensed practitioners, including physicians, dentists and
-optmeti - sts olely for uttse in their practieet or]
.. the mufaeture- preparation- prepagation- ....-
peandii, or processing of devices used solely in ree.. teaching
or analysis and which are not introduced into emmereial distribu-
tionj
(18) Misbranded Device [Misbranding] - Has the mean-
ing specified [given] in the Texas Food, Drug, and Cosmetic Act,Health and Safety Code, Chapter 431, 431.112 [as interpreted in the
rules of the board and judicial decision].
(19) Person - Includes individual, partnership, corpora-
tion, and association.
(20) Place of business - Each location at which a device
is manufactured or held for distribution.
(21) Radiation machine - Any device capable of produc-
ing ionizing radiation except those devices with radioactive material
as the only source of radiation.
(22) Radioactive material - Any material (solid, liquid,
or gas) that emits radiation spontaneously.
(23) Reconditioning - Any appropriate process or proce-
dure by which distressed merchandise can be brought into compliance
with departmental standards as specified [Has the meaning given] in
the Texas Food, Drug, Device, and Cosmetic Salvage Act, Health and
Safety Code, Chapter 432, 432.003, as interpreted in the rules of the
board in 229.192 of this title (relating to Definitions) [and judicial
decision].
(24) Restricted device - A device subject to certain
controls related to sale, distribution, or use as specified [Has the
meaning given] in the Federal Food, Drug, and Cosmetic Act, as
amended, 520(e)(1).
229.441. Minimum Standards for Licensure.
(a) Minimum requirements. All distributors or manufactur-
ers of devices engaged in the design, manufacture, packaging, la-
beling, storage, installation, and servicing [manufacturing, paki
storage, or installation] of devices must comply with the minimum
standards of this section in addition to the statutory requirements con-
tained in the Texas Food, Drug, and Cosmetic Act, Health and Safety
Code, Chapter 431 (Act). For the purpose of this section, the poli-
cies described in the United States Food and Drug Administration's
(FDA's) Compliance Policy Guides as they apply to devices shall be
the policies of the Texas Department of Health (department).
(b) (No change.)
(c) Good manufacturing practices. Device distributors or
manufacturers engaged in the design, manufacture, packaging, label-
ing, storage, installation, and servicing [manufacturingpac stor-
age or installation] of finished devices shall be in compliance with
the applicable requirements of 21 CFR, Part 820, titled "Quality Sys-
tem Regulation [Good Manufactnring Practice For Medical Devices
General]." The requirements in this part govern the methods used
in, and the facilities and controls used for, the design, manufacture,
packaging, labeling, storage, installation, and servicing [This regula-
tion sets forth the current good manufacturing practices for methods
used ira and the a fait and aentrls used fo the m featuree
paki, storage and installation] of all finished devices intended for
human use.
(d) Buildings and facilities.
(1) All manufacturing, assembling, packaging, packing,
holding, testing, or labeling of devices by manufacturers shall take
place in buildings and facilities described in 21 CFR, Part 820,
Subpart L [G], titled "Handling, Storage, Distribution, and Installation
[Buildings]."
(2) No manufacturing, assembling, packaging, packing,
holding, testing, or labeling operations of devices by manufacturers
or distributors shall be conducted in any personal residence.24 TexReg 7706 July 31, 1998 Texas Register
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Texas. Secretary of State. Texas Register, Volume 23, Number 31, Pages 7663-7938, July 31, 1998, periodical, July 31, 1998; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth113850/m1/45/: accessed July 1, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu.; crediting UNT Libraries Government Documents Department.