[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.4]

[Page 538-544]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 900--MAMMOGRAPHY--Table of Contents
 
                        Subpart A--Accreditation
 
Sec. 900.4  Standards for accreditation bodies.

    (a) Code of conduct and general responsibilities. The accreditation 
body shall accept the following responsibilities in order to ensure safe 
and accurate mammography at the facilities it accredits and shall 
perform these responsibilities in a manner that ensures the integrity 
and impartiality of accreditation body actions.
    (1)(i) When an accreditation body receives or discovers information 
that suggests inadequate image quality, or upon request by FDA, the 
accreditation body shall review a facility's clinical images or other 
aspects of a facility's practice to assist FDA in determining whether or 
not the facility's practice poses a serious risk to human health. Such 
reviews are in addition to the evaluation an accreditation body performs 
as part of the initial accreditation or renewal process for facilities.
    (ii) If review by the accreditation body demonstrates that a problem 
does exist with respect to image quality or other aspects of a 
facility's compliance with quality standards, or upon request by FDA, 
the accreditation body shall

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require or monitor corrective actions, or suspend or revoke 
accreditation of the facility.
    (2) The accreditation body shall inform FDA as soon as possible but 
in no case longer than 2 business days after becoming aware of equipment 
or practices that pose a serious risk to human health.
    (3) The accreditation body shall establish and administer a quality 
assurance (QA) program that has been approved by FDA in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality 
assurance program shall:
    (i) Include requirements for clinical image review and phantom image 
review;
    (ii) Ensure that clinical and phantom images are evaluated 
consistently and accurately; and
    (iii) Specify the methods and frequency of training and evaluation 
for clinical and phantom image reviewers, and the bases and procedures 
for removal of such reviewers.
    (4) The accreditation body shall establish measures that FDA has 
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this 
section to reduce the possibility of conflict of interest or facility 
bias on the part of individuals acting on the body's behalf. Such 
individuals who review clinical or phantom images under the provisions 
of paragraphs (c) and (d) of this section or who visit facilities under 
the provisions of paragraph (f) of this section shall not review 
clinical or phantom images from or visit a facility with which such 
individuals maintain a relationship, or when it would otherwise be a 
conflict of interest for them to do so, or when they have a bias in 
favor of or against the facility.
    (5) The accreditation body may require specific equipment 
performance or design characteristics that FDA has approved. However, no 
accreditation body shall require, either explicitly or implicitly, the 
use of any specific brand of imaging system or component, measuring 
device, software package, or other commercial product as a condition for 
accreditation by the body, unless FDA determines that it is in the best 
interest of public health to do so.
    (i) Any representation, actual or implied, either orally, in sales 
literature, or in any other form of representation, that the purchase or 
use of a particular product brand is required in order for any facility 
to be accredited or certified under Sec. 900.11(b), is prohibited, 
unless FDA approves such representation.
    (ii) Unless FDA has approved the exclusive use and promotion of a 
particular commercial product in accordance with this section, all 
products produced, distributed, or sold by an accreditation body or an 
organization that has a financial or other relationship with the 
accreditation body that may be a conflict of interest or have the 
appearance of a conflict of interest with the body's accreditation 
functions, shall bear a disclaimer stating that the purchase or use of 
such products is not required for accreditation or certification of any 
facility under Sec. 900.11(b). Any representations about such products 
shall include a similar disclaimer.
    (6) When an accreditation body denies accreditation to a facility, 
the accreditation body shall notify the facility in writing and explain 
the bases for its decision. The notification shall also describe the 
appeals process available from the accreditation body for the facility 
to contest the decision.
    (7) No accreditation body may establish requirements that preclude 
facilities from being accredited under Sec. 900.11(b) by any other 
accreditation body, or require accreditation by itself under MQSA if 
another accreditation body is available to a facility.
    (8) The accreditation body shall obtain FDA authorization for any 
changes it proposes to make in any standards that FDA has previously 
accepted under Sec. 900.3(d).
    (9) An accreditation body shall establish procedures to protect 
confidential information it collects or receives in its role as an 
accreditation body.
    (i) Nonpublic information collected from facilities for the purpose 
of carrying out accreditation body responsibilities shall not be used 
for any other purpose or disclosed, other than to FDA or its duly 
designated representatives, including State agencies, without the 
consent of the facility;

[[Page 540]]

    (ii) Nonpublic information that FDA or its duly designated 
representatives, including State agencies, share with the accreditation 
body concerning a facility that is accredited or undergoing 
accreditation by that body shall not be further disclosed except with 
the written permission of FDA.
    (b) Monitoring facility compliance with quality standards. (1) The 
accreditation body shall require that each facility it accredits meet 
standards for the performance of quality mammography that are 
substantially the same as those in this subpart and in subpart B of this 
part.
    (2) The accreditation body shall notify a facility regarding 
equipment, personnel, and other aspects of the facility's practice that 
do not meet such standards and advise the facility that such equipment, 
personnel, or other aspects of the practice should not be used by the 
facility for activities within the scope of part 900.
    (3) The accreditation body shall specify the actions that facilities 
shall take to correct deficiencies in equipment, personnel, and other 
aspects of the practice to ensure facility compliance with applicable 
standards.
    (4) If deficiencies cannot be corrected to ensure compliance with 
standards or if a facility is unwilling to take corrective actions, the 
accreditation body shall immediately so notify FDA, and shall suspend or 
revoke the facility's accreditation in accordance with the policies and 
procedures described under Sec. 900.3(b)(3)(iii)(I).
    (c) Clinical image review for accreditation and reaccreditation--(1) 
Frequency of review. The accreditation body shall review clinical images 
from each facility accredited by the body at least once every 3 years.
    (2) Requirements for clinical image attributes. The accreditation 
body shall use the following attributes for all clinical image reviews, 
unless FDA has approved other attributes:
    (i) Positioning. Sufficient breast tissue shall be imaged to ensure 
that cancers are not likely to be missed because of inadequate 
positioning.
    (ii) Compression. Compression shall be applied in a manner that 
minimizes the potential obscuring effect of overlying breast tissue and 
motion artifact.
    (iii) Exposure level. Exposure level shall be adequate to visualize 
breast structures. Images shall be neither underexposed nor overexposed.
    (iv) Contrast. Image contrast shall permit differentiation of subtle 
tissue density differences.
    (v) Sharpness. Margins of normal breast structures shall be distinct 
and not blurred.
    (vi) Noise. Noise in the image shall not obscure breast structures 
or suggest the appearance of structures not actually present.
    (vii) Artifacts. Artifacts due to lint, processing, scratches, and 
other factors external to the breast shall not obscure breast structures 
or suggest the appearance of structures not actually present.
    (viii) Examination identification. Each image shall have the 
following information indicated on it in a permanent, legible, and 
unambiguous manner and placed so as not to obscure anatomic structures:
    (A) Name of the patient and an additional patient identifier.
    (B) Date of examination.
    (C) View and laterality. This information shall be placed on the 
image in a position near the axilla. Standardized codes specified by the 
accreditation body and approved by FDA in accordance with Sec. 900.3(d) 
or paragraph (a)(8) of this section shall be used to identify view and 
laterality.
    (D) Facility name and location. At a minimum, the location shall 
include the city, State, and zip code of the facility.
    (E) Technologist identification.
    (F) Cassette/screen identification.
    (G) Mammography unit identification, if there is more than one unit 
in the facility.
    (3) Scoring of clinical images. Accreditation bodies shall establish 
and administer a system for scoring clinical images using all attributes 
specified in paragraphs (c)(2)(i) through (c)(2)(viii) of this section 
or an alternative system that FDA has approved in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section. The scoring system 
shall include an evaluation for each attribute.
    (i) The accreditation body shall establish and employ criteria for 
acceptable and nonacceptable results for each

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of the 8 attributes as well as an overall pass-fail system for clinical 
image review that has been approved by FDA in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section.
    (ii) All clinical images submitted by a facility to the 
accreditation body shall be reviewed independently by two or more review 
physicians.
    (4) Selection of clinical images for review. Unless otherwise 
specified by FDA, the accreditation body shall require that for each 
mammography unit in the facility:
    (i) The facility shall submit craniocaudal (CC) and mediolateral 
oblique (MLO) views from two mammographic examinations that the facility 
produced during a time period specified by the accreditation body;
    (ii) Clinical images submitted from one such mammographic 
examination for each unit shall be of dense breasts (predominance of 
glandular tissue) and the other shall be of fat-replaced breasts 
(predominance of adipose tissue);
    (iii) All clinical images submitted shall be images that the 
facility's interpreting physician(s) interpreted as negative or benign.
    (iv) If the facility has no clinical images meeting the requirements 
in paragraphs (c)(4)(i) through (c)(4)(iii) of this section, it shall so 
notify the accreditation body, which shall specify alternative clinical 
image selection methods that do not compromise care of the patient.
    (5) Review physicians. Accreditation bodies shall ensure that all of 
their review physicians:
    (i) Meet the interpreting physician requirements specified in 
Sec. 900.12(a)(1) and meet such additional requirements as have been 
established by the accreditation body and approved by FDA;
    (ii) Are trained and evaluated in the clinical image review process, 
for the types of clinical images to be evaluated by a review physician, 
by the accreditation body before designation as review physicians and 
periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any clinical image and provide information to the 
facility for use in improving the attributes for which significant 
deficiencies were identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to ensure the security and return to the 
facility of all clinical images received and to ensure completion of all 
clinical image reviews by the body in a timely manner. The accreditation 
body shall return all clinical images to the facility within 60 days of 
their receipt by the body, with the following exceptions:
    (i) If the clinical images are needed earlier by the facility for 
clinical purposes, the accreditation body shall cooperate with the 
facility to accommodate such needs.
    (ii) If a review physician identifies a suspicious abnormality on an 
image submitted for clinical image review, the accreditation body shall 
ensure that this information is provided to the facility and that the 
clinical images are returned to the facility. Both shall occur no later 
than 10-business days after identification of the suspected abnormality.
    (7) Notification of unsatisfactory image quality. If the 
accreditation body determines that the clinical images received from a 
facility are of unsatisfactory quality, the body shall notify the 
facility of the nature of the problem and its possible causes.
    (d) Phantom image review for accreditation and reaccreditation--(1) 
Frequency of review. The accreditation body shall review phantom images 
from each facility accredited by the body at least once every 3 years.
    (2) Requirements for the phantom used. The accreditation body shall 
require that each facility submit for review phantom images that the 
facility produced using a phantom and methods of use specified by the 
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph 
(a)(8) of this section.
    (3) Scoring phantom images. The accreditation body shall use a 
system for scoring phantom images that has been approved by FDA in 
accordance with Sec. 900.3(b) and (d) or paragraph (a)(8) of this 
section.
    (4) Phantom images selected for review. For each mammography unit in 
the facility, the accreditation body shall require the facility to 
submit phantom

[[Page 542]]

images that the facility produced during a time period specified by the 
body.
    (5) Phantom image reviewers. Accreditation bodies shall ensure that 
all of their phantom image reviewers:
    (i) Meet the requirements specified in Sec. 900.12(a)(3) or 
alternative requirements established by the accreditation body and 
approved by FDA in accordance with Sec. 900.3 or paragraph (a)(8) of 
this section;
    (ii) Are trained and evaluated in the phantom image review process, 
for the types of phantom images to be evaluated by a phantom image 
reviewer, by the accreditation body before designation as phantom image 
reviewers and periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any phantom image and provide information to the 
facility for use in improving its phantom image quality with regard to 
the significant deficiencies identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to ensure the security of all phantom images 
received and to ensure completion of all phantom image reviews by the 
body in a timely manner. All phantom images that result in a failure of 
accreditation shall be returned to the facility.
    (7) Notification measures for unsatisfactory image quality. If the 
accreditation body determines that the phantom images received from a 
facility are of unsatisfactory quality, the body shall notify the 
facility of the nature of the problem and its possible causes.
    (e) Reports of mammography equipment evaluation, surveys, and 
quality control. The following requirements apply to all facility 
equipment covered by the provisions of subparts A and B:
    (1) The accreditation body shall require every facility applying for 
accreditation to submit:
    (i) With its initial accreditation application, a mammography 
equipment evaluation that was performed by a medical physicist no 
earlier than 6 months before the date of application for accreditation 
by the facility. Such evaluation shall demonstrate compliance of the 
facility's equipment with the requirements in Sec. 900.12(e).
    (ii) Prior to accreditation, a survey that was performed no earlier 
than 6 months before the date of application for accreditation by the 
facility. Such survey shall assess the facility's compliance with the 
facility standards referenced in paragraph (b) of this section.
    (2) The accreditation body shall require that all facilities undergo 
an annual survey to ensure continued compliance with the standards 
referenced in paragraph (b) of this section and to provide continued 
oversight of facilities' quality control programs as they relate to such 
standards. The accreditation body shall require for all facilities that:
    (i) Such surveys be conducted annually;
    (ii) Facilities take reasonable steps to ensure that they receive 
reports of such surveys within 30 days of survey completion; and
    (iii) Facilities submit the results of such surveys and any other 
information that the body may require to the body at least annually.
    (3) The accreditation body shall review and analyze the information 
required in this section and use it to identify necessary corrective 
measures for facilities and to determine whether facilities should 
remain accredited by the body.
    (f) Accreditation body onsite visits and random clinical image 
reviews. The accreditation body shall conduct onsite visits and random 
clinical image reviews of a sample of facilities to monitor and assess 
their compliance with standards established by the body for 
accreditation. The accreditation body shall submit annually to FDA, at 
the address given in Sec. 900.3(b)(1), 3 copies of a summary report 
describing all facility assessments the body conducted under the 
provisions of this section for the year being reported.
    (1) Onsite visits--(i) Sample size. Annually, each accreditation 
body shall visit at least 5 percent of the facilities it accredits. 
However, a minimum of 5 facilities shall be visited, and visits to no 
more than 50 facilities are required, unless problems identified in 
paragraph (f)(1)(i)(B) of this section indicate a need to visit more 
than 50 facilities.

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    (A) At least 50 percent of the facilities visited shall be selected 
randomly.
    (B) Other facilities visited shall be selected based on problems 
identified through State or FDA inspections, serious complaints received 
from consumers or others, a previous history of noncompliance, or any 
other information in the possession of the accreditation body, 
inspectors, or FDA.
    (C) Before, during, or after any facility visit, the accreditation 
body may require that the facility submit to the body for review 
clinical images, phantom images, or any other information relevant to 
applicable standards in this subpart and in subpart B of this part.
    (ii) Visit plan. The accreditation body shall conduct facility 
onsite visits according to a visit plan that has been approved by FDA in 
accordance with Sec. 900.3(d) or paragraph (a)(8) of this section, 
unless otherwise directed by FDA in particular circumstances. At a 
minimum, such a plan shall provide for:
    (A) Assessment of overall clinical image QA activities of the 
facility;
    (B) Review of facility documentation to determine if appropriate 
mammography reports are sent to patients and physicians as required;
    (C) Selection of a sample of clinical images for clinical image 
review by the accreditation body. Clinical images shall be selected in a 
manner specified by the accreditation body and approved by FDA that does 
not compromise care of the patient as a result of the absence of the 
selected images from the facility;
    (D) Verification that the facility has a medical audit system in 
place and is correlating films and pathology reports for positive cases;
    (E) Verification that personnel specified by the facility are the 
ones actually performing designated personnel functions;
    (F) Verification that equipment specified by the facility is the 
equipment that is actually being used to perform designated equipment 
functions;
    (G) Verification that a consumer complaint mechanism is in place and 
that the facility is following its procedures; and
    (H) Review of all factors related to previously identified concerns 
or concerns identified during that visit.
    (2) Clinical image review for random sample of facilities--(i) 
Sample size. In addition to conducting clinical image reviews for 
accreditation and reaccreditation for all facilities, the accreditation 
body shall conduct clinical image reviews annually for a randomly 
selected sample as specified by FDA, but to include at least 3 percent 
of the facilities the body accredits. Accreditation bodies may count 
toward this random sample requirement all facilities selected randomly 
for the onsite visits described in paragraph (f)(1)(i)(A) of this 
section. Accreditation bodies shall not count toward the random sample 
requirement any facilities described in paragraph (f)(1)(i)(B) of this 
section that were selected for a visit because of previously identified 
concerns.
    (ii) Random clinical image review. In performing clinical image 
reviews of the random sample of facilities, accreditation bodies shall 
evaluate the same attributes as those in paragraph (c) of this section 
for review of clinical images for accreditation and reaccreditation.
    (iii) Accreditation bodies should not schedule random clinical image 
reviews at facilities that have received notification of the need to 
begin the accreditation renewal process or that have completed the 
accreditation renewal process within the previous 6 months.
    (iv) Selection of the random sample of clinical images for clinical 
image review by the accreditation body. Clinical images shall be 
selected in a manner, specified by the accreditation body and approved 
by FDA under Sec. 900.3(d) or paragraph (a)(8) of this section, that 
does not compromise care of the patient as a result of the absence of 
the selected images from the facility.
    (g) Consumer complaint mechanism. The accreditation body shall 
develop and administer a written and documented system, including 
timeframes, for collecting and resolving serious consumer complaints 
that could not be resolved at a facility. Such system shall have been 
approved by FDA in accordance withSec. 900.3(d) or paragraph (a)(8) of 
this section. Accordingly, all accreditation bodies shall:

[[Page 544]]

    (1) Provide a mechanism for all facilities it accredits to file 
serious unresolved complaints with the accreditation body;
    (2) Maintain a record of every serious unresolved complaint received 
by the body on all facilities it accredits for a period of at least 3 
years from the date of receipt of each such complaint;
    (h) Reporting and recordkeeping. All reports to FDA specified in 
paragraphs (h)(1) through (h)(4) of this section shall be prepared and 
submitted in a format and medium prescribed by FDA and shall be 
submitted to a location and according to a schedule specified by FDA. 
The accreditation body shall:
    (1) Collect and submit to FDA the information required by 42 U.S.C. 
263b(d) for each facility when the facility is initially accredited and 
at least annually when updated, in a manner and at a time specified by 
FDA.
    (2) Accept applications containing the information required in 42 
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.11(b)(3) 
for extension of provisional certificates, on behalf of FDA, and notify 
FDA of the receipt of such information;
    (3) Submit to FDA the name, identifying information, and other 
information relevant to 42 U.S.C. 263b and specified by FDA for any 
facility for which the accreditation body denies, suspends, or revokes 
accreditation, and the reason(s) for such action;
    (4) Submit to FDA an annual report summarizing all serious 
complaints received during the previous calendar year, their resolution 
status, and any actions taken in response to them;
    (5) Provide to FDA other information relevant to 42 U.S.C. 263b and 
required by FDA about any facility accredited or undergoing 
accreditation by the body.
    (i) Fees. Fees charged to facilities for accreditation shall be 
reasonable. Costs of accreditation body activities that are not related 
to accreditation functions under 42 U.S.C. 263b are not recoverable 
through fees established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different facilities.
    (2) At FDA's request, accreditation bodies shall provide financial 
records or other material to assist FDA in assessing the reasonableness 
of accreditation body fees. Such material shall be provided to FDA in a 
manner and time period specified by the agency.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
64 FR 32407, June 17, 1999]