§895.22 Submission of data and information by the manufacturer, distributor, or importer.

(a) A manufacturer, distributor, or importer of a device may be required to submit to the Food and Drug Administration all relevant and available data and information to enable the Commissioner to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. The data and information required by the Commissioner may include scientific or test data, reports, records, or other information, including data and information on whether the device is safe and effective for its intended use or when used as directed, whether the device performs according to the claims made for the device, and information on adulteration or misbranding. Any relevant information that is voluntarily submitted will also be reviewed.

(b) A manufacturer, distributor, or importer of a device required to submit data and information as provided in paragraph (a) of this section will be notified in writing by the Food and Drug Administration that such data and information shall be submitted. The written notification will advise the manufacturer, distributor, or importer of the device that the purpose for the request is to enable the Commissioner to determine whether any of the conditions listed in paragraph (a) of this section or $895.30(a)(1) exists with respect to the device such that a proceeding should be initiated to make the device a banned device. When the required data and information can be identified by the Food and Drug Administration at the time of the notification, the agency will provide such identification to the manufacturer, distributor, or importer of the device.

(c) The required data and information shall be submitted to the Food and Drug Administration no more than 30 days after the date of receipt of the request, unless the Commissioner determines that the data and information shall be submitted by some other date and so informs the manufacturer, distributor, or importer, in which case the data and information shall be submit

ted on the date specified by the Commissioner.

(d) If the data or information submitted to the Food and Drug Administration is sufficient to persuade the Commissioner that the deception or risk of illness or injury or the danger to the health of individuals presented by a device could be corrected or eliminated by labeling or change in labeling, or change in advertising if the device is a restricted device, the Commissioner will proceed in accordance with §895.25.

(e) If the data or information submitted to the Food and Drug Administration is insufficient to show that the device does not present a substantial deception or an unreasonable and substantial risk of illness or injury, or an unreasonable, direct, and substantial danger to the health of individuals, or if the manufacturer, distributor, or importer fails to submit the required information, the Commissioner may rely upon this insufficiency or failure to submit the required information in considering whether to initiate a proceeding to make the device a banned device under §895.21(d) and, when appropriate, to establish a special effective date in accordance with §895.30. The Commissioner may also initiate other regulatory action as provided in the act or this chapter.

§ 895.25 Labeling.

(a) If the Commissioner determines that the substantial deception or unreasonable and substantial risk of illness or injury or the unreasonable, direct, and substantial danger to the health of individuals presented by a device can be corrected or eliminated by labeling or a change in labeling, or change in advertising if the device is a restricted device, the Commissioner will provide written notice to the manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device specifying:

(1) The deception or risk of illness or injury or the danger to the health of individuals,

(2) The labeling or change in labeling, or change in advertising if the device is a restricted device, necessary to correct the deception or eliminate or reduce such risk or danger, and

(3) The period of time within which the labeling, change in labeling, or change in advertising must be accomEplished.

(b) In specifying the labeling or change in labeling or change in adverItising to correct the deception or to eliminate or reduce the risk of illness or injury or the danger to the health of I individuals, the Commissioner may re#quire the manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device to include in labeling for the device, and in advertising if the device is a restricted device, a statement, notice, or warning. Such stateEment, notice, or warning shall be in the manner and form prescribed by the & Commissioner and shall identify the deception or risk of illness or injury or the unreasonable, direct, and substantial danger to the health of individuals associated with the device as previously labeled. Such statement, noEtice, or warning shall be used in the labeling and advertising of the device for a time period specified by the Commissioner on the basis of the degree of deception, risk of illness or injury, or danger to health; the frequency of sale of the device; the length of time the device has been on the market; the intended uses of the device; the method of its use; and any other factors that the Commissioner considers pertinent.

(c) The Commissioner will allow a manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device a reasonable time, considering the deception or risk of illness or injury or the danger to the health of individuals presented by the device, within which to accomplish the required labeling, change in labeling, and, if the device is a restricted device, any change in advertising. The Commissioner may, however, request that no additional devices be introduced into commerce until the labeling or change in labeling, or change in advertising is accomplished by the manufacturer, distributor, importer, or other person(s) responsible for the labeling or advertising of the device.

(d) If such voluntary action is not taken, the Commissioner may take action under other sections of the act to

prevent the introduction of the devices into commerce. The Commissioner may consider the failure of a manufacturer, distributor, importer, or any other person(s) responsible for the labeling or advertising of the device to accomplish the required labeling or change in labeling, or change in advertising in accordance with this section as a basis for initiating a proceeding to make a device a banned device in accordance with §895.21(d) and when appropriate to establish a special effective date in accordance with § 895.30.

§ 895.30 Special effective date.

(a) The Commissioner may declare a proposed regulation under §895.21(d) to be effective upon its publication in the FEDERAL REGISTER and until the effective date of any final action taken respecting the regulation if:

(1) The Commissioner determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with use of the device that is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and

(2) Before the date of the publication of such regulation, the Commissioner notifies the domestic manufacturer and importer, if any, of the device that the regulation is to be made so effective. If necessary, the Commissioner may also notify the distributor or any other responsible person(s). In addition, the Commissioner will attempt to notify any foreign manufacturer when the name and address of the foreign manufacturer are readily available.

(b) This procedure may be used when the Commissioner determines that the potential or actual injury involved is a serious one that the Commissioner believes will endanger the health of individuals who have been, or will be, exposed to the device. In assessing the degree of danger, the Commissioner need not find that the danger is immediate, and it shall be sufficient for the Commissioner to determine that the danger may involve a serious long-term risk.

(c) If the Commissioner makes a proposed regulation effective in accordance with this section, the Commissioner will, as expeditiously as possible, give interested persons prompt

notice of this action in the FEDERAL REGISTER.

(d) After the hearing, if any, and after considering any written comments submitted on the proposal and any additional available information and data, the Commissioner will as expeditiously as possible either affirm, modify, or revoke the proposed regulation making the device a banned device. If the Commissioner decides to affirm or modify the proposed regulation to make a device a banned device, the Commissioner will amend Subpart B by adding the name or description of the device, or both, to the list of banned devices. If the Commissioner decides to revoke a proposed regulation making a device a banned device, a notice of termination of rulemaking proceedings and reasons therefor will be published in the FEDERAL REGISTER.

(e) The Commissioner may declare the special effective date provided by this section to be in effect after the publication of a proposed regulation under §895.21(d), if, based on new informnation, or upon reconsideration of previously available information, the Commissioner makes the determination and provides the appropriate notices and an opportunity for a hearing in accordance with paragraphs (a) and (c) of this section.

(f) Those devices that have been named banned devices under §895.30 and that have already been sold to the public may be subject to relabeling by the manufacturer, distributor, importer, or any other person(s) responsible for the labeling of the device or may be subject to the provisions of section 518(a) or (b) of the act.

[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992]

Subpart B-Listing of Banned Devices

$895.101 Prosthetic hair fibers.

Prosthetic hair fibers are devices intended for implantation into the human scalp to simulate natural hair or conceal baldness. Prosthetic hair fibers may consist of various materials; for example, synthetic fibers, such as modacrylic, polyacrylic, and polyester; and natural fibers, such as processed human hair. Excluded from the banned device are natural hair transplants, in which a person's hair and its surrounding tissue are surgically removed from one location on the person's scalp and then grafted onto another area of the person's scalp.

[48 FR 25136, June 3, 1983]

Sec.

PART 900-MAMMOGRAPHY

Subpart A-Accreditation

900.1 Scope.

900.2 Definitions.

900.3 Application for approval as an accrediting body.

900.4 Responsibilities of accrediting bodies. 900.5 Evaluation.

900.6 Withdrawal of approval.

900.7 Hearings.

Subpart B-Quality Standards and Certification

900.10 Applicability.

900.11 Requirements for certification. 900.12 Quality standards.

900.13 Revocation of accreditation and accrediting body approval.

900.14 Hearings regarding certification decisions.

900.18 Alternative requirements for MQSA quality standards.

AUTHORITY: Secs. 519, 537, and 704(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 3601, 360nn, and 374(e)); sec. 354 of the Public Health Service Act (42 U.S.C. 263b).

Subpart A-Accreditation

SOURCE: 58 FR 67562, Dec. 21, 1993, unless otherwise noted.

$900.1 Scope.

The regulations set forth in this part implement 42 U.S.C. 263b(b) through (f). The intent of subpart A of this part is to establish application procedures for accrediting bodies and to establish requirements and standards for such bodies to ensure that all mammography facilities in the United States are adequately and consistently evaluated for compliance with quality standards for mammography. The intent of subpart B of this part is to establish procedures for facility certification and to establish quality standards for mammography facilities to assure safe, reliable, and accurate mammography on a nationwide level.

$900.2 Definitions.

The following definitions apply to subparts A and B of this part:

(a) Accrediting body or body means an entity that has been approved by FDA under 42 U.S.C. 263b(e)(1)(A) to accredit mammography facilities.

(b) Certificate means the certificate described in 42 U.S.C. 263b(b)(1).

(c) Certification means the state of approval of a facility by FDA to provide screening and diagnostic mammography services.

(d) Clinical image means a mammogram.

(e) Facility means a hospital, outpatient department, clinic, radiology practice, or mobile unit, office of a physician, or other facility that conducts breast cancer screening mammography activities or conducts diagnostic mammography activities, including the following: The operation of equipment to produce a mammogram, processing of film, initial interpretation of the mammogram, and maintaining viewing conditions for that interpretation. This term does not include a facility of the Department of Veterans Affairs.

(f) Interpreting physician means a physician who interprets mammograms made during screening or diagnostic mammography procedures and who meets the requirements of §900.12(a)(1).

(g) Mammogram means a radiographic image produced through mammography.

(h) Mammography means radiography of the breast.

(i) Medical physicist means a person meeting the qualifications for a medical physicist set forth in §900.12(a)(3).

(j) Patient means any individual who undergoes clinical evaluation in a mammography facility, regardless of whether the person is referred by a physician or is self-referred.

(k) Phantom means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.

167-072 0-96--16

(1) Phantom image means a radiographic image of a phantom.

(m) Provisional certificate means the provisional certificate described in 42 U.S.C. 263b(c)(2).

(n) Radiographic equipment means Xray equipment used for the production of static x-ray images.

(0) Radiological technologist means an individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements in §900.12(a)(2).

physician

(p) Qualified practicing means a physician meeting the requirements of an interpreting physician as specified under § 900.12(a)(1).

(q) Survey means an on-site physics consultation and evaluation of a facility performed by a medical physicist.

(r) Diagnostic mammography means mammography performed on a patient with: clinical signs, symptoms, physical findings suggestive of breast cancer; an abnormal or questionable screening mammogram; a history of breast cancer with breast conservation surgery regardless of absence of clinical breast signs, symptoms, or physical findings; or, augmented breasts regardless of absence of clinical breast signs, symptoms, or physical findings. Diagnostic mammography is also called problem-solving mammography or consultative mammography. This definition excludes mammography performed during invasive interventions for localization or biopsy procedures. The definition further excludes mammography performed as part of a scientific study to evaluate an experimental mammography device conducted in accordance with FDA's investigational device exemption regulations in part 812 of this chapter.

(s) Screening mammography means mammography performed on an asymptomatic patient to detect the presence of breast cancer at an early stage. This definition excludes mammography performed as part of a scientific study to evaluate an experimental mammography device conducted in accordance with FDA's investigational device ex

emption regulations in part 812 of this chapter.

[58 FR 67562, Dec. 21, 1993; 59 FR 6899, Feb. 14, 1994, as amended at 59 FR 49812, Sept. 30, 1994]

§ 900.3 Application for approval as an accrediting body.

(a) Eligibility. Private nonprofit organizations or State agencies capable of meeting the requirements of this subpart A may apply for approval as accrediting bodies.

(b) Application. One copy of an application for approval as an accrediting body shall be submitted to the Center for Devices and Radiological Health (HFZ-200), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and should be marked ATTENTION: Mammography Program. Applications for approval as an accrediting body should include the following information:

(1) Name, address, and phone number of body and evidence of nonprofit status (i.e., of fulfilling Internal Revenue Service requirements as a nonprofit organization) if the body is not a State agency;

(2) Standards the body agrees to impose on facilities pursuant to 42 U.S.C. 263b(e)(3);

(3) Methods for performing clinical image review as required in 42 U.S.C. 263b(e)(1)(B)(i)(I);

(4) Methods for monitoring and evaluation of annual surveys of facilities by medical physicists as required in 42 U.S.C. 263b(e)(1)(B)(v);

(5) Methods for performing on-site inspections of facilities as required in 42 U.S.C. 263b(e)(4);

(6) Fee schedules, with supporting cost data; and

(7) Satisfactory assurances that the body will comply with the requirements of §900.4.

(c) Ruling on application. FDA will approve an accrediting body if FDA determines upon review of the application that the body substantially meets (or will substantially meet when it begins to evaluate facilities) the requirements of this subpart, and the body's standards are substantially the same as the quality standards published under subpart B of this part in accord