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patient notifications should the certifi- rective action, FDA determines that a cation agency determine that mam- certification agency has demonstrated mography quality has been com willful disregard for public health, has promised to such an extent that it may committed fraud, has failed to provide present a serious risk to human health. adequate resources for the program,
(h) Electronic data transmission. There has submitted material false stateshall be processes to ensure the timeli- ments to the agency, has failed to ness and accuracy of electronic trans achieve the MQSA goals of quality mission of inspection data and facility mammography and access, or has percertification status information in a formed or failed to perform a delegated format and timeframe determined by function in a manner that may canse FDA.
serious risk to human health, FDA (i) Changes to standards. A certifi may withdraw its approval of that cercation agency shall obtain FDA au tification agency. The certification thorization for any changes it proposes agency shall notify, within a time pe to make in any standard that FDA has riod and in a manner approved by FDA previously accepted under $900.21 be- all facilities certified or seeking cerfore requiring facilities to comply with tification by it that it has been rethe changes as a condition of obtaining quired to correct major deficiencies. or maintaining certification.
(1) FDA shall notify the certification
agency of FDA's action and the 8 900.23 Evaluation.
grounds on which the approval was FDA shall evaluate annually the per- withdrawn. formance of each certification agency. (2) A certification agency that has The evaluation shall include the use of lost its approval shall notify facilities performance indicators that address certified or seeking certification by it, the adequacy of program performance as well as the appropriate accreditain certification, inspection, and en tion bodies with jurisdiction in the forcement activities. FDA will also State, that its approval has been withconsider any additional information drawn. Such notification shall be made deemed relevant by FDA that has been within a timeframe and in a manner provided by the certification body or approved by FDA. other sources or has been required by (b) Minor deficiencies. If FDA deterFDA as part of its oversight mandate. mines that a certification agency has The evaluation also shall include a re demonstrated deficiencies in perview of any changes in the standards or forming certification functions and reprocedures in the areas listed in sponsibilities that are less serious of 88 900.21(b) and 900.22 that have taken more limited than the deficiencies in place since the original application or paragraph (a) of this section, including the last evaluation, whichever is most failure to follow the certification ageirecent. The evaluation shall include a cy's own procedures and policies as ap determination of whether there are proved by FDA, FDA shall notify the major deficiencies in the certification certification agency that it has a spec agency's regulations or performance fied period of time to take particular that, if not corrected, would warrant corrective measures as directed by withdrawal of the approval of the cer FDA or to submit to FDA for approval tification agency under the provisions the certification agency's own plan of of $900.24, or minor deficiencies that corrective action addressing the minor would require corrective action.
deficiencies. If the approved corrective
actions are not being implemented sat$ 900.24 Withdrawal of approval.
isfactorily or within the established If FDA determines, through the eval schedule, FDA may place the agency uation activities of $900.23, or through on probationary status for a period of other means, that a certification agen time determined by FDA, or may withcy is not in substantial compliance draw approval of the certification with this subpart, FDA may initiate agency. the following actions:
(1) If FDA places a certification agen(a) Major deficiencies. If, after pro- cy on probationary status, the certifividing notice and opportunity for cor- cation agency shall notify all facilities
rtified or seeking certification by it timeframe and in a manner approved ? its probationary status within a by FDA. me period and in a manner approved (c) Transfer of records. A certification 7 FDA.
agency that has its approval with(2) Probationary status shall remain drawn shall transfer facility records effect until such time as the certifi
and other related information as reition agency can demonstrate to the
quired by FDA to a location and actisfaction of FDA that it has success
cording to a schedule approved by lly implemented or is implementing
FDA. le corrective action plan within the
$ 900.25 Hearings and appeals. tablished schedule, and that the cor
(a) Opportunities to challenge final ictive actions have substantially iminated all identified problems, or
adverse actions taken by FDA regard
ing approval of certification agencies (3) If FDA determines that a certifi
or withdrawal of approval of certifiition agency that has been placed on
cation agencies shall be communicated robationary status is not imple
through notices of opportunity for inlenting corrective actions satisfac
formal hearings in accordance with srily or within the established sched
part 16 of this chapter. le, FDA may withdraw approval of the
(b) A facility that has been denied ertification agency. The certification
certification is entitled to an appeals gency shall notify all facilities cer process from the certification agency. fied or seeking certification by it, as The appeals process shall be specified ell as the appropriate accreditation in writing by the certification agency odies with jurisdiction in the State, of and shall have been approved by FDA is loss of FDA approval, within a in accordance with 88 900.21 and 900.22.
Subpart A-General Provisions
Sec. 1000.1 General. 1000.3 Definitions.
Subpart B-Statements of Policy and
Interpretation 1000.15 Examples of electronic products sub
ject to the Radiation Control for Health and Safety Act of 1968.
Subpart C-Radiation Protection
Recommendations 1000.50 Recommendation for the use of spe
cific area gonad shielding on patients during medical diagnostic X-ray proce
dures. 1000.55 Recommendation for quality assur
ance programs in diagnostic radiology fa
cilities. 1000.60 Recommendation on administra
tively required dental X-ray examina
tions. AUTHORITY: 21 U.S.C. 360hh-360ss.
SOURCE: 38 FR 28624, Oct. 15, 1973, unless otherwise noted.
(c) Chassis family means a group of one or more models with all of the following common characteristics:
(1) The same circuitry in the high voltage, horizontal oscillator, and power supply sections;
(2) The same worst component failures;
(3) The same type of high voltage hold-down or safety circuits; and
(4) The same design and installation. (d) Commerce means:
(1) Commerce between any place in any State and any place outside thereof, and
(2) Commerce wholly within the District of Columbia.
(e) Component, for the purposes of this part, means an essential functional part of a subassembly or of an assembled electronic product, and which may affect the quantity, quality, direction, or radiation emission of the finished product.
(f) Dealer means a person engaged in the business of offering electronic products for sale to purchasers, without regard to whether such person is or has been primarily engaged in such business, and includes persons who offer such products for lease or as prizes or awards.
(g) Director means the Director of the Center for Devices and Radiological Health.
(h) Distributor means a person engaged in the business of offering electronic products for sale to dealers, without regard to whether such person is or has been primarily or customarily engaged in such business.
(i) Electromagnetic radiation includes the entire electromagnetic spectrum of radiation of any wavelength. The electromagnetic spectrum illustrated in figure 1 includes, but is not limited to, gamma rays, x-rays, ultra-violet, visible, infrared, microwave, radioware, and low frequency radiation.
Subpart A-General Provisions
$ 1000.1 General.
References in this subchapter J to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (50 FR 33688, Aug. 20, 1985) $ 1000.3 Definitions.
As used in this subchapter J:
(a) Accidental radiation occurrence means a single event or series of events that has have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.
(b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360hh-360ss).
i) Electronic product means:
tion 534 of the Federal Food, Drug, and 1) Any manufactured or assembled Cosmetic Act. duct which, when in operation:
(m) Infrasonic, sonic (or audible) and i) Contains or acts as part of an elec
ultrasonic waves refer to energy transnic circuit and
mitted as an alteration (pressure, parii) Emits (or in the absence of effec
ticle displacement or density) in a e shielding or other controls would
property of an elastic medium (gas, liqit) electronic product radiation, or
uid or solid) that can be detected by an 2) Any manufactured or assembled
instrument or listener. ticle that is intended for use as a
(n) Manufacturer means any person mponent, part, or accessory of a
engaged in the business of manufacoduct described in paragraph (j)(1) of
turing, assembling, or importing elecis section and which, when in operion, emits (or in the absence of effec
tronic products. Te shielding or other controls would
(0) Model means any identifiable, nit) such radiation.
unique electronic product design, and (k) Electronic product radiation means:
refers to products having the same (1) Any ionizing or nonionizing elec
structural and electrical design characomagnetic or particulate radiation,
teristics and to which the manufac
turer has assigned a specific designa(2) Any sonic, infrasonic, or ultra
tion to differentiate between it and inic wave that is emitted from an other products produced by that manuectronic product as the result of the facturer. peration of an electronic circuit in (p) Model family means products hav
ing similar design and radiation char(1) Federal standard means a perform acteristics but different manufacturer nce standard issued pursuant to sec- model numbers.
(q) Modified model means a product that is redesigned so that actual or potential radiation emission, the manner of compliance with a standard, or the manner of radiation safety testing is affected.
(r) Particulate radiation is defined as:
(1) Charged particles, such as protons, electrons, alpha particles, or heavy particles, which have sufficient kinetic energy to produce ionization or atomic or electron excitation by collision, electrical attractions or electrical repulsion; or
(2) Uncharged particles, such as neutrons, which can initiate a nuclear transformation or liberate charged particles having sufficient kinetic energy to produce ionization or atomic or electron excitation.
(s) Phototherapy product means any ultraviolet lamp, or product containing such lamp, that is intended for irradiation of any part of the living human body by light in the wavelength range of 200 to 400 nanometers, in order to perform a therapeutic function.
(t) Purchaser means the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and includes a person who leases an electronic product for purposes other than subleasing.
(u) State means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa. [60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996]
search, educational). Particulate radiation and ionizing electro
magnetic radiation: Electron microscopes. Neutron generators.
(b) Examples of electronic products which may emit ultraviolet, visible, infrared, microwaves, radio and low frequency electromagnetic radiation include: Ultraviolet: Biochemical and medical analyzers. Tanning and therapeutic lamps. Sanitizing and sterilizing devices. Black light sources. Welding equipment. Visible:
White light devices.
Dryers, ovens, and heaters.
(c) Examples of electronic products which may emit coherent electromagnetic radiation produced by stimulated emission include:
Subpart B-Statements of Policy
$ 1000.15 Examples of electronic prod
ucts subject to the Radiation Control for Health and Safety Act of
1968. The following listed electronic products are intended to serve as illustrative examples of sources of electronic product radiation to which the regulations of this part apply.
(a) Examples of electronic products which may emit x-rays and other ionizing electromagnetic radiation, electrons, neutrons, and other particulate radiation include: Ionizing electromagnetic radiation:
(d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include: Infrasonic: