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 information, 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]

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.

8900.2 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 O-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 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

ance with 42 U.S.C. 263b(f). If the applicant fails to substantially meet the requirements set forth in this subpart A, or if the applicant's standards are determined not to be substantially the same as the quality standards pubMlished under subpart B of this part, or

if FDA determines that the applicant has not provided satisfactory assurances that it is capable of meeting the requirements established in this subApart A, FDA will notify the applicant of any problems it has identified with the application and request that the applicant resolve such problems within 90 days of receipt of notice. If the problems are substantially resolved to the satisfaction of FDA within the 90-day time period, the body will be approved as an accrediting body. If the problems are not substantially resolved to the satisfaction of FDA within the 90-day time period, the application for approval as an accrediting body will be rejected and the applicant so notified. A rejected application that has been modified so as to render it satisfactory is subject to resubmission at any time.

$900.4 Responsibilities of accrediting bodies.

(a) Facility standards. The accrediting body shall require that each facility it accredits meet standards for the performance

of quality mammography that are substantially the same as those promulgated in subpart B of this part under 42 U.S.C. 263b(f). The requirements set forth by the body for accreditation of a facility shall address, at a minimum, the following aspects of performing quality mammography:

quality mammography is practiced by the facility;

(6) Phantom image quality testing and objective criteria to be used for passing the image quality test;

(7) Maximum radiation dose for a single view for specific imaging systems;

(8) Information update provisions that require accredited facilities to update at least annually the information listed in this section that they have provided the accrediting body; and

(9) Medical recordkeeping and patient notification requirements.

(b) Clinical image review. The accrediting body shall review clinical images from each facility accredited by the body at least once every 3 years and shall also review a random sample of clinical images from each facility accredited by the body in each 3-year period beginning October 1, 1994. These clinical image reviews shall be conducted by a qualified practicing physician not associated with the facility. The clinical image reviews shall ensure that quality clinical images are produced in the facility on a routine basis, as measured by proper breast positioning and compression and overall image quality. Any qualified practicing physicians who conduct clinical image quality reviews shall not have a financial interest in the facilities they review for the accrediting body, nor shall such physicians have any other interest that would constitute an apparent or real conflict of interest, other than receiving a service fee from the accrediting body itself related solely to the work performed in conducting the clinical review.

(c) Fees. Fees charged to facilities for accreditation shall be reasonable. FDA will usually find fees to be reasonable if they are limited to recovering costs to the accrediting body, including overhead incurred proportionately in accrediting a given facility. Accrediting bodies may adjust fees annually for inflation in accordance with the Consumer Price Index (CPI).

(d) Reports of physics survey. (1) The accrediting body shall require every facility applying for accreditation to submit to the accrediting body, with its accreditation application, a report of a survey by a medical physicist to assess the facility's compliance with

the accrediting body's standards established under paragraph (a) of this section. The accrediting body shall require that every facility it accredits undergo an annual survey by a medical physicist to assure continued facility compliance with applicable standards and to provide continued oversight of the facility's quality assurance program. The accrediting body shall require that the results of this survey be transmitted to the accrediting body, together with quality control records and any other information the body may require, as a part of the annual report about the facility.

(2) The accrediting body shall review the report of the annual physicist's survey, the quality control records of the facility, and other information that may come to its attention to determine if all the accrediting body's standards are being met by the facility. If the results of the survey or other information create doubt as to the quality of clinical images produced by the facility, then the accrediting body shall investigate by examination of recent clinical images from that facility to verify that the images meet the evaluation criteria of the accrediting body. If the accrediting body determines that the images are not of sufficient quality, the body shall determine necessary corrective measures to be taken by the facility, establish a schedule for implementation of such measures, and notify the facility that it must implement these measures within the specified schedule in order to retain accreditation. The accrediting body shall verify that the appropriate and necessary steps are taken by the facility within the schedule specified and that all accrediting body standards are being substantially met or will be substantially met. However, the responsibility for compliance remains with the facility.

(e) On-site inspections. On an annual basis, in accordance with methods specified in the accrediting body's application for approval, the accrediting body shall make on-site visits to a sufficient number of facilities accredited by the body to assess overall compliance with the accrediting body standards and the quality of performance of mammography. The accrediting body

shall prepare and submit one copy of a report of the findings of each of these visits to FDA at the address specified in §900.3(b). The facility may be given advance notice at the discretion of the accrediting body.

(f) Complaints. The accrediting body shall require all facilities it accredits to publish an address where complaints can be filed with the accrediting body, shall investigate such complaints within 90 days of receipt, and shall maintain records of all of such complaints for a period of 3 years from the time of completion of the investigation. Complaint records shall include a summary of the complaint and of the results of the accrediting body's investigation.

(g) Reporting and recordkeeping. All reporting requirements listed in this section shall be fulfilled by the accrediting body by sending reports to FDA at the address specified in §900.3(b). Reports required within 48 hours may be made by phone initially but must be followed by a written notification within 5 days. The accrediting body shall:

(1) Comply with any reporting and recordkeeping requirements specified in paragraphs (a) through (f) of this section;

(2) submit to FDA the names of any facilities for which the accrediting body denies, suspends, or revokes accreditation, and the basis for the action, within 48 hours of the action;

(3) obtain FDA authorization for any change the accrediting body proposes to make in the standards of the body under § 900.3(c);

(4) collect the information required by 42 U.S.C. 263b(d) for each facility accredited by the body and submit it to FDA within 5 days of the date of accreditation;

(5) accept applications containing the information required in 42 U.S.C. 263b(c)(2) for provisional certificates and in §900.11(b)(2) for extensions of provisional certificates, on behalf of FDA and notify FDA within 5 working days of the successful completion of the initial application; and

(6) provide to FDA any information requested by FDA about any particular facility accredited by the body within 5 days of receipt of the request.