Quality Mammography Standards; Correction

SUMMARY: The Food and Drug Administration (FDA) is correcting a

document entitled ``Quality Mammography Standards'' that appeared in

the Federal Register of October 28, 1997. The document was published

with some inadvertent typographical errors and incorrect dates in the

regulatory text. This document corrects those errors. FDA is also

identifying with greater specificity those sections of the quality

standards that will become effective October 28, 2002. For the

convenience of the reader, FDA is republishing 21 CFR part 900 in its

entirety with corrections.

DATES: This regulation is effective April 28, 1999; except

Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), (e)(5)(i)(B) which become

effective October 28, 2002.

FOR FURTHER INFORMATION CONTACT: Roger Burkhart, Center for Devices and

Radiological Health (HFZ-240), Food and Drug Administration 5600

Fishers Lane, Rockville, MD 20850, 301-594-3332, FAX 301-594-3306.

SUPPLEMENTARY INFORMATION: In FR Doc. 97-26351, appearing on page 55852

in the Federal Register of Tuesday, October 28, 1997, the following

corrections are made:

1. On page 55852, in the first column, the ``DATES'' section is

corrected as set forth above.

2. On page 55854, in the first column, in the third full paragraph,

line 12, ``Mammography Matters'' should be italicized.

3. On page 55872, in the first column, in the fourth full

paragraph, in line 14, the ``+'' sign is corrected to read

``''.

4. On page 55895, in the second column, in the fifth paragraph, in

line 16, ``gi11'' is removed and the paragraph is indented at

``(Comment 225)''.

5. On page 55919, in the third column, in the fourth full

paragraph, in line 4, in the fifth full paragraph, in line 5, and in

the sixth full paragraph, in line 5, the ``+'' sign is corrected to

read ``''.

6. On page 55920, in the first column, in lines 1 and 6, the ``+''

sign is corrected to read ``''; and in the second column,

in the first full paragraph, in line 7, ``(10-4'' is corrected to read

``(10-4''.

7. On page 55930, in the second column, in the third line from the

bottom, the word ``patents'' is corrected to read ``patients''.

8. On page 55938, in the third column, in the second full

paragraph, in line 19, ``advided'' is corrected to read ``advised''.

9. On page 55954, in the first column, in the seventh paragraph,

beginning in line 6, ``Journal of the Medical Association'' should be

italicized.

10. On page 55967, in the first column, in the third line from the

bottom of the page, ``becauseit'' is corrected to read ``because it''.

11. On page 55975, in the second column, in the second full

paragraph, line 7, ``(C).'' is corrected to read ``. (C)''; and in the

third full paragraph, in line 4, ``(B).'' is corrected to read ``.

(B)''.

12. On page 55976, in the second column, in reference 5, in line 2,

``'' is corrected to read ``''; and in line 3,

``1995-1993'' is corrected to read ``1993-1995''.

Part 16 [Corrected]

13. On page 55976, in the authority citation for 21 CFR part 16,

``41-40'' is corrected to read ``40-41''; and in amendatory instruction

2., in the section heading, ``Sec. 716.1'' is corrected to read

``Sec. 16.1''.

Sec. 900.3 [Corrected]

14. On page 55979, in the second column in Sec. 900.3(c)(4), a

comma is inserted after ``July 28, 1998''.

Sec. 900.12 [Corrected]

15. On page 55986, in the first column, in the introductory text of

Sec. 900.12(a)(2)(iv), a comma is inserted after ``October 28, 1997''.

16. On page 55987, in the second column, in Sec. 900.12(b)(6)(ii)

the word ``valve'' is corrected to read ``value''; in

Sec. 900.12(b)(8)(i), ``October 28, 1999'' is corrected to read

``October 28, 2002''.

17. On page 55989, in the first column, in Sec. 900.12(e)(1)(ii),

(iii), (e)(2)(ii), and (e)(5)(ii) the ``+'' sign is corrected to read

``''; and in Sec. 900.12(e)(4)(iii)(B), (e)(5)(i)(B), and

(e)(5)(iii) ``October 28, 1999'' is corrected to read ``October 28,

2002'' each time it appears.

18. On page 55990, in the third column, in Sec. 900.12(e)(5)(x)(A),

``October 28, 1999'' is corrected to read ``October 28, 2002''.

19. On page 55991, in the third column, in Sec. 900.12(e)(12) the

``+'' sign is corrected to read ``''.

20. On page 55992, in the heading for Sec. 900.12(h), the word

``compliant'' is corrected to read ``complaint''.

Sec. 900.18 [Corrected]

21. On page 55993, in Sec. 900.18(a)(1), the word ``assuing'' is

corrected to read ``assuring''.

As corrected, 21 CFR part 900 is republished to read as follows:

PART 900--MAMMOGRAPHY

Subpart A--Accreditation

Sec.

900.1 Scope.

900.2 Definitions.

900.3 Application for approval as an accreditation body.

900.4 Standards for accreditation bodies.

900.5 Evaluation.

900.6 Withdrawal of approval.

900.7 Hearings.

900.8--900.9 [Reserved]

Subpart B--Quality Standards and Certification

900.10 Applicability.

900.11 Requirements for certification.

900.12 Quality standards.

900.13 Revocation of accreditation and revocation of accreditation

body approval.

900.14 Suspension or revocation of certificates.

900.15 Appeals of adverse accreditation or reaccreditation

decisions that preclude certification or recertification.

900.16 Appeals of denials of certification.

900.17 [Reserved]

900.18 Alternative requirements for Sec. 900.12 quality standards.

Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

Subpart A--Accreditation

Sec. 900.1 Scope.

The regulations set forth in this part implement the Mammography

Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part

establishes procedures whereby an entity can apply to become a Food and

Drug Administration (FDA)-approved accreditation body to accredit

facilities to be eligible to perform screening or diagnostic

mammography services. Subpart A further establishes requirements and

standards for accreditation bodies to ensure that all mammography

facilities under the jurisdiction of the United States are adequately

and consistently evaluated for compliance with national quality

standards for mammography. Subpart B of this part establishes minimum

national quality standards for mammography facilities to ensure safe,

reliable, and accurate mammography. The regulations set forth in this

part do

[[Page 60615]]

not apply to facilities of the Department of Veterans Affairs.

Sec. 900.2 Definitions.

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

(a) Accreditation body or body means an entity that has been

approved by FDA under Sec. 900.3(d) to accredit mammography facilities.

(b) Action limits or action levels means the minimum and maximum

values of a quality assurance measurement that can be interpreted as

representing acceptable performance with respect to the parameter being

tested. Values less than the minimum or greater than the maximum action

limit or level indicate that corrective action must be taken by the

facility. Action limits or levels are also sometimes called control

limits or levels.

(c) Adverse event means an undesirable experience associated with

mammography activities within the scope of 42 U.S.C. 263b. Adverse

events include but are not limited to:

(1) Poor image quality;

(2) Failure to send mammography reports within 30 days to the

referring physician or in a timely manner to the self-referred patient;

and

(3) Use of personnel that do not meet the applicable requirements

of Sec. 900.12(a).

(d) Air kerma means kerma in a given mass of air. The unit used to

measure the quantity of air kerma is the Gray (Gy). For X-rays with

energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 radian (rad)

= 114 roentgens (R) of exposure.

(e) Breast implant means a prosthetic device implanted in the

breast.

(f) Calendar quarter means any one of the following time periods

during a given year: January 1 through March 31, April 1 through June

30, July 1 through September 30, or October 1 through December 31.

(g) Category I means medical educational activities that have been

designated as Category I by the Accreditation Council for Continuing

Medical Education (ACCME), the American Osteopathic Association (AOA),

a state medical society, or an equivalent organization.

(h) Certificate means the certificate described in Sec. 900.11(a).

(i) Certification means the process of approval of a facility by

FDA to provide mammography services.

(j) Clinical image means a mammogram.

(k) Consumer means an individual who chooses to comment or complain

in reference to a mammography examination, including the patient or

representative of the patient (e.g., family member or referring

physician).

(l) Continuing education unit or continuing education credit means

one contact hour of training.

(m) Contact hour means an hour of training received through direct

instruction.

(n) Direct instruction means:

(1) Face-to-face interaction between instructor(s) and student(s),

as when the instructor provides a lecture, conducts demonstrations, or

reviews student performance; or

(2) The administration and correction of student examinations by an

instructor(s) with subsequent feedback to the student(s).

(o) Direct supervision means that:

(1) During joint interpretation of mammograms, the supervising

interpreting physician reviews, discusses, and confirms the diagnosis

of the physician being supervised and signs the resulting report before

it is entered into the patient's records; or

(2) During the performance of a mammography examination or survey

of the facility's equipment and quality assurance program, the

supervisor is present to observe and correct, as needed, the

performance of the individual being supervised who is performing the

examination or conducting the survey.

(p) Established operating level means the value of a particular

quality assurance parameter that has been established as an acceptable

normal level by the facility's quality assurance program.

(q) Facility means a hospital, outpatient department, clinic,

radiology practice, mobile unit, office of a physician, or other

facility that conducts mammography activities, including the following:

Operation of equipment to produce a mammogram, processing of the

mammogram, 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.

(r) First allowable time means the earliest time a resident

physician is eligible to take the diagnostic radiology boards from an

FDA-designated certifying body. The ``first allowable time'' may vary

with the certifying body.

(s) FDA means the Food and Drug Administration.

(t) Interim regulations means the regulations entitled

``Requirements for Accrediting Bodies of Mammography Facilities'' (58

FR 67558-67565) and ``Quality Standards and Certification Requirements

for Mammography Facilities'' (58 FR 67565-67572), published by FDA on

December 21, 1993, and amended on September 30, 1994 (59 FR 49808-

49813). These regulations established the standards that had to be met

by mammography facilities in order to lawfully operate between October

1, 1994, and April 28, 1999.

(u) Interpreting physician means a licensed physician who

interprets mammograms and who meets the requirements set forth in

Sec. 900.12(a)(1).

(v) Kerma means the sum of the initial energies of all the charged

particles liberated by uncharged ionizing particles in a material of

given mass.

(w) Laterality means the designation of either the right or left

breast.

(x) Lead interpreting physician means the interpreting physician

assigned the general responsibility for ensuring that a facility's

quality assurance program meets all of the requirements of

Sec. 900.12(d) through (f). The administrative title and other

supervisory responsibilities of the individual, if any, are left to the

discretion of the facility.

(y) Mammogram means a radiographic image produced through

mammography.

(z) Mammographic Modality means a technology, within the scope of

42 U.S.C. 263b, for radiography of the breast. Examples are screen-film

mammography and xeromammography.

(aa) Mammography means radiography of the breast, but, for the

purposes of this part, does not include:

(1) Radiography of the breast performed during invasive

interventions for localization or biopsy procedures; or

(2) Radiography of the breast performed with an investigational

mammography device as part of a scientific study conducted in

accordance with FDA's investigational device exemption regulations in

part 812 of this chapter.

(bb) Mammography equipment evaluation means an onsite assessment of

mammography unit or image processor performance by a medical physicist

for the purpose of making a preliminary determination as to whether the

equipment meets all of the applicable standards in Sec. 900.12(b) and

(e).

(cc) Mammography medical outcomes audit means a systematic

collection of mammography results and the comparison of those results

with outcomes data.

(dd) Mammography unit or units means an assemblage of components

for the production of X-rays for use during mammography, including, at

a minimum: An X-ray generator, an X-ray

[[Page 60616]]

control, a tube housing assembly, a beam limiting device, and the

supporting structures for these components.

(ee) Mean optical density means the average of the optical

densities measured using phantom thicknesses of 2, 4, and 6 centimeters

with values of kilovolt peak (kVp) clinically appropriate for those

thicknesses.

(ff) Medical physicist means a person trained in evaluating the

performance of mammography equipment and facility quality assurance

programs and who meets the qualifications for a medical physicist set

forth in Sec. 900.12(a)(3).

(gg) MQSA means the Mammography Quality Standards Act.

(hh) Multi-reading means two or more physicians, at least one of

whom is an interpreting physician, interpreting the same mammogram.

(ii) Patient means any individual who undergoes a mammography

evaluation in a facility, regardless of whether the person is referred

by a physician or is self-referred.

(jj) 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.

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

(ll) Physical science means physics, chemistry, radiation science

(including medical physics and health physics), and engineering.

(mm) Positive mammogram means a mammogram that has an overall

assessment of findings that are either ``suspicious'' or ``highly

suggestive of malignancy.''

(nn) Provisional certificate means the provisional certificate

described in Sec. 900.11(b)(2).

(oo) Qualified instructor means an individual whose training and

experience adequately prepares him or her to carry out specified

training assignments. Interpreting physicians, radiologic

technologists, or medical physicists who meet the requirements of

Sec. 900.12(a) would be considered qualified instructors in their

respective areas of mammography. Other examples of individuals who may

be qualified instructors for the purpose of providing training to meet

the regulations of this part include, but are not limited to,

instructors in a post-high school training institution and

manufacturer's representatives.

(pp) Quality control technologist means an individual meeting the

requirements of Sec. 900.12(a)(2) who is responsible for those quality

assurance responsibilities not assigned to the lead interpreting

physician or to the medical physicist.

(qq) Radiographic equipment means X-ray equipment used for the

production of static X-ray images.

(rr) Radiologic 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

set forth in Sec. 900.12(a)(2).

(ss) Serious adverse event means an adverse advent that may

significantly compromise clinical outcomes, or an adverse event for

which a facility fails to take appropriate corrective action in a

timely manner.

(tt) Serious complaint means a report of a serious adverse event.

(uu) Standard breast means a 4.2 centimeter (cm) thick compressed

breast consisting of 50 percent glandular and 50 percent adipose

tissue.

(vv) Survey means an onsite physics consultation and evaluation of

a facility quality assurance program performed by a medical physicist.

(ww) Time cycle means the film development time.

(xx) Traceable to a national standard means an instrument is

calibrated at either the National Institute of Standards and Technology

(NIST) or at a calibration laboratory that participates in a

proficiency program with NIST at least once every 2 years and the

results of the proficiency test conducted within 24 months of

calibration show agreement within 3 percent of the

national standard in the mammography energy range.

Sec. 900.3 Application for approval as an accreditation body.

(a) Eligibility. Private nonprofit organizations or State agencies

capable of meeting the requirements of this subpart A may apply for

approval as accreditation bodies.

(b) Application for initial approval. (1) An applicant seeking

initial FDA approval as an accreditation body shall inform the Division

of Mammography Quality and Radiation Programs (DMQRP), Center for

Devices and Radiology Health (HFZ-240), Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850, marked Attn: Mammography

Standards Branch, of its desire to be approved as an accreditation body

and of its requested scope of authority.

(2) Following receipt of the request, FDA will provide the

applicant with additional information to aid in submission of an

application for approval as an accreditation body.

(3) The applicant shall furnish to FDA, at the address in

Sec. 900.3(b)(1), three copies of an application containing the

following information, materials, and supporting documentation:

(i) Name, address, and phone number of the applicant and, if the

applicant is not a State agency, evidence of nonprofit status (i.e., of

fulfilling Internal Revenue Service requirements as a nonprofit

organization);

(ii) Detailed description of the accreditation standards the

applicant will require facilities to meet and a discussion

substantiating their equivalence to FDA standards required under

Sec. 900.12;

(iii) Detailed description of the applicant's accreditation review

and decisionmaking process, including:

(A) Procedures for performing accreditation and reaccreditation

clinical image review in accordance with Sec. 900.4(c), random clinical

image reviews in accordance with Sec. 900.4(f), and additional

mammography review in accordance with Sec. 900.12(j);

(B) Procedures for performing phantom image review;

(C) Procedures for assessing mammography equipment evaluations and

surveys;

(D) Procedures for initiating and performing onsite visits to

facilities;

(E) Procedures for assessing facility personnel qualifications;

(F) Copies of the accreditation application forms, guidelines,

instructions, and other materials the applicant will send to facilities

during the accreditation process, including an accreditation history

form that requires each facility to provide a complete history of prior

accreditation activities and a statement that all information and data

submitted in the application is true and accurate, and that no material

fact has been omitted;

(G) Policies and procedures for notifying facilities of

deficiencies;

(H) Procedures for monitoring corrections of deficiencies by

facilities;

(I) Policies and procedures for suspending or revoking a facility's

accreditation;

(J) Policies and procedures that will ensure processing of

accreditation applications and renewals within a timeframe approved by

FDA and assurances that the body will adhere to such policies and

procedures; and

(K) A description of the applicant's appeals process for facilities

contesting adverse accreditation status decisions.

(iv) Education, experience, and training requirements for the

applicant's professional staff, including reviewers of clinical or

phantom images;

(v) Description of the applicant's electronic data management and

[[Page 60617]]

analysis system with respect to accreditation review and decision

processes and the applicant's ability to provide electronic data in a

format compatible with FDA data systems;

(vi) Resource analysis that demonstrates that the applicant's

staffing, funding, and other resources are adequate to perform the

required accreditation activities;

(vii) Fee schedules with supporting cost data;

(viii) Statement of policies and procedures established to avoid

conflicts of interest or the appearance of conflicts of interest by the

applicant's board members, commissioners, professional personnel

(including reviewers of clinical and phantom images), consultants,

administrative personnel, and other representatives of the applicant;

(ix) Statement of policies and procedures established to protect

confidential information the applicant will collect or receive in its

role as an accreditation body;

(x) Disclosure of any specific brand of imaging system or

component, measuring device, software package, or other commercial

product used in mammography that the applicant develops, sells, or

distributes;

(xi) Description of the applicant's consumer complaint mechanism;

(xii) Satisfactory assurances that the applicant shall comply with

the requirements of Sec. 900.4; and

(xiii) Any other information as may be required by FDA.

(c) Application for renewal of approval. An approved accreditation

body that intends to continue to serve as an accreditation body beyond

its current term shall apply to FDA for renewal or notify FDA of its

plans not to apply for renewal in accordance with the following

procedures and schedule:

(1) At least 9 months before the date of expiration of a body's

approval, the body shall inform FDA, at the address given in

Sec. 900.3(b)(1), of its intent to seek renewal.

(2) FDA will notify the applicant of the relevant information,

materials, and supporting documentation required under Sec. 900.3(b)(3)

that the applicant shall submit as part of the renewal procedure.

(3) At least 6 months before the date of expiration of a body's

approval, the applicant shall furnish to FDA, at the address in

Sec. 900.3(b)(1), three copies of a renewal application containing the

information, materials, and supporting documentation requested by FDA

in accordance with Sec. 900.3(c)(2).

(4) No later than July 28, 1998, any accreditation body approved

under the interim regulations published in the Federal Register of

December 21, 1993 (58 FR 67558), that desires to continue to serve as

an accreditation body under the final regulations shall apply for

renewal of approval in accordance with the procedures set forth in

paragraphs (c)(1) through (c)(3) of this section.

(5) Any accreditation body that does not plan to renew its approval

shall so notify FDA at the address given in paragraph (b)(1) of this

section at least 9 months before the expiration of the body's term of

approval.

(d) Rulings on applications for initial and renewed approval. (1)

FDA will conduct a review and evaluation to determine whether the

applicant substantially meets the applicable requirements of this

subpart and whether the accreditation standards the applicant will

require facilities to meet are substantially the same as the quality

standards published under subpart B of this part.

(2) FDA will notify the applicant of any deficiencies in the

application and request that those deficiencies be rectified within a

specified time period. If the deficiencies are not rectified to FDA's

satisfaction within the specified time period, the application for

approval as an accreditation body may be rejected.

(3) FDA shall notify the applicant whether the application has been

approved or denied. That notification shall list any conditions

associated with approval or state the bases for any denial.

(4) The review of any application may include a meeting between FDA

and representatives of the applicant at a time and location mutually

acceptable to FDA and the applicant.

(5) FDA will advise the applicant of the circumstances under which

a denied application may be resubmitted.

(6) If FDA does not reach a final decision on a renewal application

in accordance with this paragraph before the expiration of an

accreditation body's current term of approval, the approval will be

deemed extended until the agency reaches a final decision on the

application, unless an accreditation body does not rectify deficiencies

in the application within the specified time period, as required in

paragraph (d)(2) of this section.

(e) Relinquishment of authority. An accreditation body that decides

to relinquish its accreditation authority before expiration of the

body's term of approval shall submit a letter of such intent to FDA, at

the address in Sec. 900.3(b)(1), at least 9 months before relinquishing

such authority.

(f) Transfer of records. An accreditation body that does not apply

for renewal of accreditation body approval, is denied such approval by

FDA, or relinquishes its accreditation authority and duties before

expiration of its term of approval, shall:

(1) Transfer facility records and other related information as

required by FDA to a location and according to a schedule approved by

FDA.

(2) Notify, in a manner and time period approved by FDA, all

facilities accredited or seeking accreditation by the body that the

body will no longer have accreditation authority.

(g) Scope of authority. An accreditation body's term of approval is

for a period not to exceed 7 years. FDA may limit the scope of

accreditation authority.

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 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:

[[Page 60618]]

(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 financial 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;

(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.

[[Page 60619]]

(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 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

clinical image reviewers.

(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) Clinical image reviewers. Accreditation bodies shall ensure

that all of their clinical image reviewers:

(i) Meet the interpreting physician requirements specified in

Sec. 900.12(a)(1);

(ii) Are trained and evaluated in the clinical image review

process, for the types of clinical images to be evaluated by a clinical

image reviewer, by the accreditation body before designation as

clinical image reviewers 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 clinical image reviewer 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 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;

[[Page 60620]]

(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.

(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:

(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

[[Page 60621]]

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.

Sec. 900.5 Evaluation.

FDA shall evaluate annually the performance of each accreditation

body. Such evaluation shall include an assessment of the reports of FDA

or State inspections of facilities accredited by the body as well as

any additional information deemed relevant by FDA that has been

provided by the accreditation body or other sources or has been

required by FDA as part of its oversight initiatives. The evaluation

shall include a determination of whether there are major deficiencies

in the accreditation body's performance that, if not corrected, would

warrant withdrawal of the approval of the accreditation body under the

provisions of Sec. 900.6.

Sec. 900.6 Withdrawal of approval.

If FDA determines, through the evaluation activities of Sec. 900.5,

or through other means, that an accreditation body is not in

substantial compliance with this subpart, FDA may initiate the

following actions:

(a) Major deficiencies. If FDA determines that an accreditation

body has failed to perform a major accreditation function

satisfactorily, has demonstrated willful disregard for public health,

has violated the code of conduct, has committed fraud, or has submitted

material false statements to the agency, FDA may withdraw its approval

of that accreditation body.

(1) FDA shall notify the accreditation body of the agency's action

and the grounds on which the approval was withdrawn.

(2) An accreditation body that has lost its approval shall notify

facilities accredited or seeking accreditation by it that its approval

has been withdrawn. Such notification shall be made within a time

period and in a manner approved by FDA.

(b) Minor deficiencies. If FDA determines that an accreditation

body has demonstrated deficiencies in performing accreditation

functions and responsibilities that are less serious or more limited

than the deficiencies in paragraph (a) of this section, FDA shall

notify the body that it has a specified period of time to take

particular corrective measures directed by FDA or to submit to FDA for

approval the body's own plan of corrective action addressing the minor

deficiencies. FDA may place the body on probationary status for a

period of time determined by FDA, or may withdraw approval of the body

as an accreditation body if corrective action is not taken.

(1) If FDA places an accreditation body on probationary status, the

body shall notify all facilities accredited or seeking accreditation by

it of its probationary status within a time period and in a manner

approved by FDA.

(2) Probationary status shall remain in effect until such time as

the body can demonstrate to the satisfaction of FDA that it has

successfully implemented or is implementing the corrective action plan

within the established schedule, and that the corrective actions have

substantially eliminated all identified problems.

(3) If FDA determines that an accreditation body that has been

placed on probationary status is not implementing corrective actions

satisfactorily or within the established schedule, FDA may withdraw

approval of the accreditation body. The accreditation body shall notify

all facilities accredited or seeking accreditation by it of its loss of

FDA approval, within a time period and in a manner approved by FDA.

(c) Reapplication by accreditation bodies that have had their

approval withdrawn. (1) A former accreditation body that has had its

approval withdrawn may submit a new application for approval if the

body can provide information to FDA to establish that the problems that

were grounds for withdrawal of approval have been resolved.

(2) If FDA determines that the new application demonstrates that

the body satisfactorily has addressed the causes of its previous

unacceptable performance, FDA may reinstate approval of the

accreditation body.

(3) FDA may request additional information or establish additional

conditions that must be met by a former accreditation body before FDA

approves the reapplication.

(4) FDA may refuse to accept an application from a former

accreditation body whose approval was withdrawn because of fraud or

willful disregard of public health.

Sec. 900.7 Hearings.

(a) Opportunities to challenge final adverse actions taken by FDA

regarding approval or reapproval of accreditation bodies, withdrawal of

approval of accreditation bodies, or rejection of a proposed fee for

accreditation shall be communicated through notices of opportunity for

informal hearings in accordance with part 16 of this chapter.

(b) A facility that has been denied accreditation is entitled to an

appeals process from the accreditation body. The appeals process shall

be specified in writing by the accreditation body and shall have been

approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).

(c) A facility that cannot achieve satisfactory resolution of an

adverse accreditation decision through the accreditation body's appeals

process may appeal to FDA for reconsideration in accordance with

Sec. 900.15.

Secs. 900.8--900.9 [Reserved]

Subpart B--Quality Standards and Certification

Sec. 900.10 Applicability.

The provisions of subpart B are applicable to all facilities under

the regulatory jurisdiction of the United States that provide

mammography services, with the exception of the Department of Veterans

Affairs.

Sec. 900.11 Requirements for certification.

(a) General. After October 1, 1994, a certificate issued by FDA is

required for lawful operation of all mammography facilities subject to

the provisions of this subpart. To obtain a certificate from FDA,

facilities are required to meet the quality standards in Sec. 900.12

and to be accredited by an approved accreditation body or other entity

as designated by FDA.

(b) Application. (1) Certificates. (i) In order to qualify for a

certificate, a facility must apply to an FDA-approved accreditation

body, or to another entity designated by FDA. The facility shall submit

to such body or entity the information required in 42 U.S.C.

263b(d)(1).

(ii) Following the agency's receipt of the accreditation body's

decision to accredit a facility, or an equivalent decision by another

entity designated by FDA, the agency may issue a certificate to the

facility, or renew an existing certificate, if the agency determines

that the facility has satisfied the requirements for certification or

recertification.

(2) Provisional certificates. (i) A new facility beginning

operation after October 1, 1994, is eligible to apply for a provisional

certificate. The provisional certificate will enable the facility to

perform mammography and to obtain

[[Page 60622]]

the clinical images needed to complete the accreditation process. To

apply for and receive a provisional certificate, a facility must meet

the requirements of 42 U.S.C. 263b(c)(2) and submit the necessary

information to an approved accreditation body or other entity

designated by FDA.

(ii) Following the agency's receipt of the accreditation body's

decision that a facility has submitted the required information, FDA

may issue a provisional certificate to a facility upon determination

that the facility has satisfied the requirements of

Sec. 900.11(b)(2)(i). A provisional certificate shall be effective for

up to 6 months from the date of issuance. A provisional certificate

cannot be renewed, but a facility may apply for a 90-day extension of

the provisional certificate.

(3) Extension of provisional certificate. (i) To apply for a 90-

day extension to a provisional certificate, a facility shall submit to

its accreditation body, or other entity designated by FDA, a statement

of what the facility is doing to obtain certification and evidence that

there would be a significant adverse impact on access to mammography in

the geographic area served if such facility did not obtain an

extension.

(ii) The accreditation body shall forward the request, with its

recommendation, to FDA within 2 business days after receipt.

(iii) FDA may issue a 90-day extension for a provisional

certificate upon determination that the extension meets the criteria

set forth in 42 U.S.C. 263b(c)(2).

(iv) There can be no renewal of a provisional certificate beyond

the 90-day extension.

(c) Reinstatement policy. A previously certified facility that has

allowed its certificate to expire, that has been refused a renewal of

its certificate by FDA, or that has had its certificate suspended or

revoked by FDA, may apply to have the certificate reinstated so that

the facility may be considered to be a new facility and thereby be

eligible for a provisional certificate.

(1) Unless prohibited from reinstatement under Sec. 900.11(c)(4), a

facility applying for reinstatement shall:

(i) Contact an FDA-approved accreditation body or other entity

designated by FDA to determine the requirements for reapplication for

accreditation;

(ii) Fully document its history as a previously provisionally

certified or certified mammography facility, including the following

information:

(A) Name and address of the facility under which it was previously

provisionally certified or certified;

(B) Name of previous owner/lessor;

(C) FDA facility identification number assigned to the facility

under its previous certification; and

(D) Expiration date of the most recent FDA provisional certificate

or certificate; and

(iii) Justify application for reinstatement of accreditation by

submitting to the accreditation body or other entity designated by FDA,

a corrective action plan that details how the facility has corrected

deficiencies that contributed to the lapse of, denial of renewal, or

revocation of its certificate.

(2) FDA may issue a provisional certificate to the facility if:

(i) The accreditation body or other entity designated by FDA

notifies the agency that the facility has adequately corrected, or is

in the process of correcting, pertinent deficiencies; and

(ii) FDA determines that the facility has taken sufficient

corrective action since the lapse of, denial of renewal, or revocation

of its previous certificate.

(3) After receiving the provisional certificate, the facility may

lawfully resume performing mammography services while completing the

requirements for certification.

(4) If a facility's certificate was revoked on the basis of an act

described in 41 U.S.C. 263b(i)(1), no person who owned or operated that

facility at the time the act occurred may own or operate a mammography

facility within 2 years of the date of revocation.

Sec. 900.12 Quality standards.

(a) Personnel. The following requirements apply to all personnel

involved in any aspect of mammography, including the production,

processing, and interpretation of mammograms and related quality

assurance activities:

(1) Interpreting physicians. All physicians interpreting mammograms

shall meet the following qualifications:

(i) Initial qualifications. Unless the exemption in paragraph

(a)(1)(iii)(A) of this section applies, before beginning to interpret

mammograms independently, the interpreting physician shall:

(A) Be licensed to practice medicine in a State;

(B)(1) Be certified in an appropriate specialty area by a body

determined by FDA to have procedures and requirements adequate to

ensure that physicians certified by the body are competent to interpret

radiological procedures, including mammography; or

(2) Have had at least 3 months of documented formal training in the

interpretation of mammograms and in topics related to mammography. The

training shall include instruction in radiation physics, including

radiation physics specific to mammography, radiation effects, and

radiation protection. The mammographic interpretation component shall

be under the direct supervision of a physician who meets the

requirements of paragraph (a)(1) of this section;

(C) Have a minimum of 60 hours of documented medical education in

mammography, which shall include: Instruction in the interpretation of

mammograms and education in basic breast anatomy, pathology,

physiology, technical aspects of mammography, and quality assurance and

quality control in mammography. All 60 of these hours shall be category

I and at least 15 of the category I hours shall have been acquired

within the 3 years immediately prior to the date that the physician

qualifies as an interpreting physician. Hours spent in residency

specifically devoted to mammography will be considered as equivalent to

Category I continuing medical education credits and will be accepted if

documented in writing by the appropriate representative of the training

institution; and

(D) Unless the exemption in paragraph (a)(1)(iii)(B) of this

section applies, have interpreted or multi-read at least 240

mammographic examinations within the 6-month period immediately prior

to the date that the physician qualifies as an interpreting physician.

This interpretation or multi-reading shall be under the direct

supervision of an interpreting physician.

(ii) Continuing experience and education. All interpreting

physicians shall maintain their qualifications by meeting the following

requirements:

(A) Following the second anniversary date of the end of the

calendar quarter in which the requirements of paragraph (a)(1)(i) of

this section were completed, the interpreting physician shall have

interpreted or multi-read at least 960 mammographic examinations during

the 24 months immediately preceding the date of the facility's annual

MQSA inspection or the last day of the calendar quarter preceding the

inspection or any date in-between the two. The facility will choose one

of these dates to determine the 24-month period.

(B) Following the third anniversary date of the end of the calendar

quarter in which the requirements of paragraph (a)(1)(i) of this

section were completed,

[[Page 60623]]

the interpreting physician shall have taught or completed at least 15

category I continuing medical education units in mammography during the

36 months immediately preceding the date of the facility's annual MQSA

inspection or the last day of the calendar quarter preceding the

inspection or any date in between the two. The facility will choose one

of these dates to determine the 36-month period. This training shall

include at least six category I continuing medical education credits in

each mammographic modality used by the interpreting physician in his or

her practice; and

(C) Before an interpreting physician may begin independently

interpreting mammograms produced by a new mammographic modality, that

is, a mammographic modality in which the physician has not previously

been trained, the interpreting physician shall have at least 8 hours of

training in the new mammographic modality.

(D) Units earned through teaching a specific course can be counted

only once towards the 15 required by paragraph (a)(1)(ii)(B) of this

section, even if the course is taught multiple times during the

previous 36 months.

(iii) Exemptions. (A) Those physicians who qualified as

interpreting physicians under paragraph (a)(1) of this section of FDA's

interim regulations prior to April 28, 1999, are considered to have met

the initial requirements of paragraph (a)(1)(i) of this section. They

may continue to interpret mammograms provided they continue to meet the

licensure requirement of paragraph (a)(1)(i)(A) of this section and the

continuing experience and education requirements of paragraph

(a)(1)(ii) of this section.

(B) Physicians who have interpreted or multi-read at least 240

mammographic examinations under the direct supervision of an

interpreting physician in any 6-month period during the last 2 years of

a diagnostic radiology residency and who become appropriately board

certified at the first allowable time, as defined by an eligible

certifying body, are otherwise exempt from paragraph (a)(1)(i)(D) of

this section.

(iv) Reestablishing qualifications. Interpreting physicians who

fail to maintain the required continuing experience or continuing

education requirements shall reestablish their qualifications before

resuming the independent interpretation of mammograms, as follows:

(A) Interpreting physicians who fail to meet the continuing

experience requirements of paragraph (a)(1)(ii)(A) of this section

shall:

(1) Interpret or multi-read at least 240 mammographic examinations

under the direct supervision of an interpreting physician, or

(2) Interpret or multi-read a sufficient number of mammographic

examinations, under the direct supervision of an interpreting

physician, to bring the physician's total up to 960 examinations for

the prior 24 months, whichever is less.

(3) The interpretations required under paragraph (a)(1)(iv)(A)(1)

or (a)(1)(iv)(A)(2) of this section shall be done within the 6 months

immediately prior to resuming independent interpretation.

(B) Interpreting physicians who fail to meet the continuing

education requirements of paragraph (a)(1)(ii)(B) of this section shall

obtain a sufficient number of additional category I continuing medical

education credits in mammography to bring their total up to the

required 15 credits in the previous 36 months before resuming

independent interpretation.

(2) Radiologic technologists. All mammographic examinations shall

be performed by radiologic technologists who meet the following general

requirements, mammography requirements, and continuing education and

experience requirements:

(i) General requirements. (A) Be licensed to perform general

radiographic procedures in a State; or

(B) Have general certification from one of the bodies determined by

FDA to have procedures and requirements adequate to ensure that

radiologic technologists certified by the body are competent to perform

radiologic examinations; and

(ii) Mammography requirements. Have, prior to April 28, 1999,

qualified as a radiologic technologist under paragraph (a)(2) of this

section or completed at least 40 contact hours of documented training

specific to mammography under the supervision of a qualified

instructor. The hours of documented training shall include, but not

necessarily be limited to:

(A) Training in breast anatomy and physiology, positioning and

compression, quality assurance/quality control techniques, imaging of

patients with breast implants;

(B) The performance of a minimum of 25 examinations under the

direct supervision of an individual qualified under paragraph (a)(2) of

this section; and

(C) At least 8 hours of training in each mammography modality to be

used by the technologist in performing mammography exams; and

(iii) Continuing education requirements. (A) Following the third

anniversary date of the end of the calendar quarter in which the

requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section

were completed, the radiologic technologist shall have taught or

completed at least 15 continuing education units in mammography during

the 36 months immediately preceding the date of the facility's annual

MQSA inspection or the last day of the calendar quarter preceding the

inspection or any date in between the two. The facility will choose one

of these dates to determine the 36-month period.

(B) Units earned through teaching a specific course can be counted

only once towards the 15 required in paragraph (a)(2)(iii)(A) of this

section, even if the course is taught multiple times during the

previous 36 months.

(C) At least six of the continuing education units required in

paragraph (a)(2)(iii)(A) of this section shall be related to each

mammographic modality used by the technologist.

(D) Requalification. Radiologic technologists who fail to meet the

continuing education requirements of paragraph (a)(2)(iii)(A) of this

section shall obtain a sufficient number of continuing education units

in mammography to bring their total up to at least 15 in the previous 3

years, at least 6 of which shall be related to each modality used by

the technologist in mammography. The technologist may not resume

performing unsupervised mammography examinations until the continuing

education requirements are completed.

(E) Before a radiologic technologist may begin independently

performing mammographic examinations using a mammographic modality

other than one of those for which the technologist received training

under paragraph (a)(2)(ii)(C) of this section, the technologist shall

have at least 8 hours of continuing education units in the new

modality.

(iv) Continuing experience requirements. (A) Following the second

anniversary date of the end of the calendar quarter in which the

requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section

were completed or of October 28, 1997, whichever is later, the

radiologic technologist shall have performed a minimum of 200

mammography examinations during the 24 months immediately preceding the

date of the facility's annual MQSA inspection or the last day of the

calendar quarter or any date in between the two. The facility will

choose one of

[[Page 60624]]

these dates to determine the 24-month period.

(B) Requalification. Radiologic technologists who fail to meet the

continuing experience requirements of paragraph (a)(2)(iv)(A) of this

section shall perform a minimum of 25 mammography examinations under

the direct supervision of a qualified radiologic technologist, before

resuming the performance of unsupervised mammography examinations.

(3) Medical physicists. All medical physicists conducting surveys

of mammography facilities and providing oversight of the facility

quality assurance program under paragraph (e) of this section shall

meet the following:

(i) Initial qualifications. (A) Be State licensed or approved or

have certification in an appropriate specialty area by one of the

bodies determined by FDA to have procedures and requirements to ensure

that medical physicists certified by the body are competent to perform

physics survey; and

(B)(1) Have a masters degree or higher in a physical science from

an accredited institution, with no less than 20 semester hours or

equivalent (e.g., 30 quarter hours) of college undergraduate or

graduate level physics;

(2) Have 20 contact hours of documented specialized training in

conducting surveys of mammography facilities; and

(3) Have the experience of conducting surveys of at least 1

mammography facility and a total of at least 10 mammography units. No

more than one survey of a specific unit within a period of 60 days can

be counted towards the total mammography unit survey requirement. After

April 22, 1999, experience conducting surveys must be acquired under

the direct supervision of a medical physicist who meets all the

requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section;

or

(ii) Alternative initial qualifications. (A) Have qualified as a

medical physicist under paragraph (a)(3) of this section of FDA's

interim regulations and retained that qualification by maintenance of

the active status of any licensure, approval, or certification required

under the interim regulations; and

(B) Prior to the April 22, 1999, have:

(1) A bachelor's degree or higher in a physical science from an

accredited institution with no less than 10 semester hours or

equivalent of college undergraduate or graduate level physics,

(2) Forty contact hours of documented specialized training in

conducting surveys of mammography facilities and,

(3) Have the experience of conducting surveys of at least 1

mammography facility and a total of at least 20 mammography units. No

more than one survey of a specific unit within a period of 60 days can

be counted towards the total mammography unit survey requirement. The

training and experience requirements must be met after fulfilling the

degree requirement.

(iii) Continuing qualifications. (A) Continuing education.

Following the third anniversary date of the end of the calendar quarter

in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this

section were completed, the medical physicist shall have taught or

completed at least 15 continuing education units in mammography during

the 36 months immediately preceding the date of the facility's annual

inspection or the last day of the calendar quarter preceding the

inspection or any date in between the two. The facility shall choose

one of these dates to determine the 36-month period. This continuing

education shall include hours of training appropriate to each

mammographic modality evaluated by the medical physicist during his or

her surveys or oversight of quality assurance programs. Units earned

through teaching a specific course can be counted only once towards the

required 15 units in a 36-month period, even if the course is taught

multiple times during the 36 months.

(B) Continuing experience. Following the second anniversary date of

the end of the calendar quarter in which the requirements of paragraph

(a)(3)(i) or (a)(3)(ii) of this section were completed or of October

28, 1997, whichever is later, the medical physicist shall have surveyed

at least two mammography facilities and a total of at least six

mammography units during the 24 months immediately preceding the date

of the facility's annual MQSA inspection or the last day of the

calendar quarter or any date in-between the two. The facility shall

choose one of these dates to determine the 24-month period. No more

than one survey of a specific facility within a 10-month period on a

specific unit within a period of 60 days can be counted towards the

total mammography unit survey requirement.

(C) Before a medical physicist may begin independently performing

mammographic surveys of a new mammographic modality, that is, a

mammographic modality other than one for which the physicist received

training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this

section, the physicist must receive at least 8 hours of training in

surveying units of the new mammographic modality.

(iv) Reestablishing qualifications. Medical physicists who fail to

maintain the required continuing qualifications of paragraph

(a)(3)(iii) of this section may not perform the MQSA surveys without

the supervision of a qualified medical physicist. Before independently

surveying another facility, medical physicists must reestablish their

qualifications, as follows:

(A) Medical physicists who fail to meet the continuing educational

requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a

sufficient number of continuing education units to bring their total

units up to the required 15 in the previous 3 years.

(B) Medical physicists who fail to meet the continuing experience

requirement of paragraph (a)(3)(iii)(B) of this section shall complete

a sufficient number of surveys under the direct supervision of a

medical physicist who meets the qualifications of paragraphs (a)(3)(i)

and (a)(3)(iii) of this section to bring their total surveys up to the

required two facilities and six units in the previous 24 months. No

more than one survey of a specific unit within a period of 60 days can

be counted towards the total mammography unit survey requirement.

(4) Retention of personnel records. Facilities shall maintain

records to document the qualifications of all personnel who worked at

the facility as interpreting physicians, radiologic technologists, or

medical physicists. These records must be available for review by the

MQSA inspectors. Records of personnel no longer employed by the

facility should not be discarded until the next annual inspection has

been completed and FDA has determined that the facility is in

compliance with the MQSA personnel requirements.

(b) Equipment. Regulations published under Secs. 1020.30, 1020.31,

and 900.12(e) of this chapter that are relevant to equipment

performance should also be consulted for a more complete understanding

of the equipment performance requirements.

(1) Prohibited equipment. Radiographic equipment designed for

general purpose or special nonmammography procedures shall not be used

for mammography. This prohibition includes systems that have been

modified or equipped with special attachments for mammography. This

requirement supersedes the implied acceptance of such systems in

Sec. 1020.31(f)(3) of this chapter.

(2) General. All radiographic equipment used for mammography shall

[[Page 60625]]

be specifically designed for mammography and shall be certified

pursuant to Sec. 1010.2 of this chapter as meeting the applicable

requirements of Secs. 1020.30 and 1020.31 of this chapter in effect at

the date of manufacture.

(3) Motion of tube-image receptor assembly. (i) The assembly shall

be capable of being fixed in any position where it is designed to

operate. Once fixed in any such position, it shall not undergo

unintended motion.

(ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of

this section shall not fail in the event of power interruption.

(4) Image receptor sizes. (i) Systems using screen-film image

receptors shall provide, at a minimum, for operation with image

receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.

(ii) Systems using screen-film image receptors shall be equipped

with moving grids matched to all image receptor sizes provided.

(iii) Systems used for magnification procedures shall be capable of

operation with the grid removed from between the source and image

receptor.

(5) Beam limitation and light fields. (i) All systems shall have

beam-limiting devices that allow the useful beam to extend to or beyond

the chest wall edge of the image receptor.

(ii) For any mammography system with a light beam that passes

through the X-ray beam-limiting device, the light shall provide an

average illumination of not less than 160 lux (15 foot candles) at 100

cm or the maximum source-image receptor distance (SID), whichever is

less.

(6) Magnification. (i) Systems used to perform noninterventional

problem solving procedures shall have radiographic magnification

capability available for use by the operator.

(ii) Systems used for magnification procedures shall provide, at a

minimum, at least one magnification value within the range of 1.4 to

2.0.

(7) Focal spot selection. (i) When more than one focal spot is

provided, the system shall indicate, prior to exposure, which focal

spot is selected.

(ii) When more than one target material is provided, the system

shall indicate, prior to exposure, the preselected target material.

(iii) When the target material and/or focal spot is selected by a

system algorithm that is based on the exposure or on a test exposure,

the system shall display, after the exposure, the target material and/

or focal spot actually used during the exposure.

(8) Compression. All mammography systems shall incorporate a

compression device.

(i) Application of compression. Effective October 28, 2002, each

system shall provide:

(A) An initial power-driven compression activated by hands-free

controls operable from both sides of the patient; and

(B) Fine adjustment compression controls operable from both sides

of the patient.

(ii) Compression paddle. (A) Systems shall be equipped with

different sized compression paddles that match the sizes of all full-

field image receptors provided for the system. Compression paddles for

special purposes, including those smaller than the full size of the

image receptor (for ``spot compression'') may be provided. Such

compression paddles for special purposes are not subject to the

requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this

section.

(B) Except as provided in paragraph (b)(8)(ii)(C) of this section,

the compression paddle shall be flat and parallel to the breast support

table and shall not deflect from parallel by more than 1.0 cm at any

point on the surface of the compression paddle when compression is

applied.

(C) Equipment intended by the manufacturer's design to not be flat

and parallel to the breast support table during compression shall meet

the manufacturer's design specifications and maintenance requirements.

(D) The chest wall edge of the compression paddle shall be straight

and parallel to the edge of the image receptor.

(E) The chest wall edge may be bent upward to allow for patient

comfort but shall not appear on the image.

(9) Technique factor selection and display. (i) Manual selection of

milliampere seconds (mA's) or at least one of its component parts

(milliapere (mA) and/or time) shall be available.

(ii) The technique factors (peak tube potential in kilovolt (kV)

and either tube current in mA and exposure time in seconds or the

product of tube current and exposure time in mA's) to be used during an

exposure shall be indicated before the exposure begins, except when

automatic exposure controls (AEC) are used, in which case the technique

factors that are set prior to the exposure shall be indicated.

(iii) Following AEC mode use, the system shall indicate the actual

kilovoltage peak (kVp) and mA's used during the exposure. The mA's may

be displayed as mA and time.

(10) Automatic exposure control. (i) Each screen-film system shall

provide an AEC mode that is operable in all combinations of equipment

configuration provided, e.g., grid, nongrid; magnification,

nonmagnification; and various target-filter combinations.

(ii) The positioning or selection of the detector shall permit

flexibility in the placement of the detector under the target tissue.

(A) The size and available positions of the detector shall be

clearly indicated at the X-ray input surface of the breast compression

paddle.

(B) The selected position of the detector shall be clearly

indicated.

(iii) The system shall provide means for the operator to vary the

selected optical density from the normal (zero) setting.

(11) X-ray film. The facility shall use X-ray film for mammography

that has been designated by the film manufacturer as appropriate for

mammography.

(12) Intensifying screens. The facility shall use intensifying

screens for mammography that have been designated by the screen

manufacturer as appropriate for mammography and shall use film that is

matched to the screen's spectral output as specified by the

manufacturer.

(13) Film processing solutions. For processing mammography films,

the facility shall use chemical solutions that are capable of

developing the films used by the facility in a manner equivalent to the

minimum requirements specified by the film manufacturer.

(14) Lighting. The facility shall make special lights for film

illumination, i.e., hot-lights, capable of producing light levels

greater than that provided by the view box, available to the

interpreting physicians.

(15) Film masking devices. Facilities shall ensure that film

masking devices that can limit the illuminated area to a region equal

to or smaller than the exposed portion of the film are available to all

interpreting physicians interpreting for the facility.

(c) Medical records and mammography reports--(1) Contents and

terminology. Each facility shall prepare a written report of the

results of each mammography examination performed under its

certificate. The mammography report shall include the following

information:

(i) The name of the patient and an additional patient identifier;

(ii) Date of examination;

(iii) The name of the interpreting physician who interpreted the

mammogram;

(iv) Overall final assessment of findings, classified in one of the

following categories:

[[Page 60626]]

(A) ``Negative:'' Nothing to comment upon (if the interpreting

physician is aware of clinical findings or symptoms, despite the

negative assessment, these shall be explained);

(B) ``Benign:'' Also a negative assessment;

(C) ``Probably Benign:'' Finding(s) has a high probability of being

benign;

(D) ``Suspicious:'' Finding(s) without all the characteristic

morphology of breast cancer but indicating a definite probability of

being malignant;

(E) ``Highly suggestive of malignancy:'' Finding(s) has a high

probability of being malignant;

(v) In cases where no final assessment category can be assigned due

to incomplete work-up, ``Incomplete: Need additional imaging

evaluation'' shall be assigned as an assessment and reasons why no

assessment can be made shall be stated by the interpreting physician;

and

(vi) Recommendations made to the health care provider about what

additional actions, if any, should be taken. All clinical questions

raised by the referring health care provider shall be addressed in the

report to the extent possible, even if the assessment is negative or

benign.

(2) Communication of mammography results to the patient. Each

facility shall maintain a system to ensure that the results of each

mammographic examination are communicated to the patient in a timely

manner. If assessments are ``Suspicious'' or ``Highly suggestive of

malignancy'' and the patient has not named a health care provider, the

facility shall make reasonable attempts to ensure that the results are

communicated to the patient as soon as possible.

(i) As soon as possible, but no later than 30 days from the date of

the mammography examination, patients who do not name a health care

provider to receive the mammography report shall be sent the report

described in paragraph (c)(1) of this section, in addition to a written

notification of results in lay terms.

(ii) Each facility that accepts patients who do not have a primary

care provider shall maintain a system for referring such patients to a

health care provider when clinically indicated.

(3) Communication of mammography results to health care providers.

When the patient has a referring health care provider or the patient

has named a health care provider, the facility shall:

(i) Provide a written report of the mammography examination,

including the items listed in paragraph (c)(1) of this section, to that

health care provider as soon as possible, but no later than 30 days

from the date of the mammography examination; and

(ii) If the assessment is ``Suspicious'' or ``Highly suggestive of

malignancy,'' make reasonable attempts to communicate with the health

care provider as soon as possible, or if the health care provider is

unavailable, to a responsible designee of the health care provider.

(4) Recordkeeping. Each facility that performs mammograms: (i)

Shall (except as provided in paragraph (c)(3)(ii) of this section)

maintain mammography films and reports in a permanent medical record of

the patient for a period of not less than 5 years, or not less than 10

years if no additional mammograms of the patient are performed at the

facility, or a longer period if mandated by State or local law; and

(ii) Shall upon request or on behalf of, by the patient,

permanently or temporarily transfer the original mammograms and copies

of the patient's reports to a medical institution, or to a physician or

health care provider of the patient, or to the patient directly;

(iii) Any fee charged to the patients for providing the services in

paragraph (c)(4)(ii) of this section shall not exceed the documented

costs associated with this service.

(5) Mammographic image identification. Each mammographic 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:

(i) Name of patient and an additional patient identifier.

(ii) Date of examination.

(iii) 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(b) or Sec. 900.4(a)(8) shall be used to identify view and

laterality.

(iv) Facility name and location. At a minimum, the location shall

include the city, State, and zip code of the facility.

(v) Technologist identification.

(vi) Cassette/screen identification.

(vii) Mammography unit identification, if there is more than one

unit in the facility.

(d) Quality assurance--general. Each facility shall establish and

maintain a quality assurance program to ensure the safety, reliability,

clarity, and accuracy of mammography services performed at the

facility.

(1) Responsible individuals. Responsibility for the quality

assurance program and for each of its elements shall be assigned to

individuals who are qualified for their assignments and who shall be

allowed adequate time to perform these duties.

(i) Lead interpreting physician. The facility shall identify a lead

interpreting physician who shall have the general responsibility of

ensuring that the quality assurance program meets all requirements of

paragraphs (d) through (f) of this section. No other individual shall

be assigned or shall retain responsibility for quality assurance tasks

unless the lead interpreting physician has determined that the

individual's qualifications for, and performance of, the assignment are

adequate.

(ii) Interpreting physicians. All interpreting physicians

interpreting mammograms for the facility shall:

(A) Follow the facility procedures for corrective action when the

images they are asked to interpret are of poor quality, and

(B) Participate in the facility's medical outcomes audit program.

(iii) Medical physicist. Each facility shall have the services of a

medical physicist available to survey mammography equipment and oversee

the equipment-related quality assurance practices of the facility. At a

minimum, the medical physicist(s) shall be responsible for performing

the surveys and mammography equipment evaluations and providing the

facility with the reports described in paragraphs (e)(9) and (e)(10) of

this section.

(iv) Quality control technologist. Responsibility for all

individual tasks within the quality assurance program not assigned to

the lead interpreting physician or the medical physicist shall be

assigned to a quality control technologist(s). The tasks are to be

performed by the quality control technologist or by other personnel

qualified to perform the tasks. When other personnel are utilized for

these tasks, the quality control technologist shall ensure that the

tasks are completed in such a way as to meet the requirements of

paragraph (e) of this section.

(2) Quality assurance records. The lead interpreting physician,

quality control technologist, and medical physicist shall ensure that

records concerning employee qualifications to meet assigned quality

assurance tasks, mammography technique and procedures, quality control

(including monitoring data, problems detected by analysis of that data,

corrective actions, and the effectiveness of the corrective actions),

safety, and protection are properly maintained and updated. These

quality control records shall be

[[Page 60627]]

kept for each test specified in paragraphs (e) and (f) of this section

until the next annual inspection has been completed and FDA has

determined that the facility is in compliance with the quality

assurance requirements or until the test has been performed two

additional times at the required frequency, whichever is longer.

(e) Quality assurance--equipment--(1) Daily quality control tests.

Film processors used to develop mammograms shall be adjusted and

maintained to meet the technical development specifications for the

mammography film in use. A processor performance test shall be

performed on each day that examinations are performed before any

clinical films are processed that day. The test shall include an

assessment of base plus fog density, mid-density, and density

difference, using the mammography film used clinically at the facility.

(i) The base plus fog density shall be within + 0.03 of the

established operating level.

(ii) The mid-density shall be within 0.15 of the

established operating level.

(iii) The density difference shall be within 0.15 of

the established operating level.

(2) Weekly quality control tests. Facilities with screen-film

systems shall perform an image quality evaluation test, using an FDA-

approved phantom, at least weekly.

(i) The optical density of the film at the center of an image of a

standard FDA-accepted phantom shall be at least 1.20 when exposed under

a typical clinical condition.

(ii) The optical density of the film at the center of the phantom

image shall not change by more than 0.20 from the

established operating level.

(iii) The phantom image shall achieve at least the minimum score

established by the accreditation body and accepted by FDA in accordance

with Sec. 900.3(d) or Sec. 900.4(a)(8).

(iv) The density difference between the background of the phantom

and an added test object, used to assess image contrast, shall be

measured and shall not vary by more than 0.05 from the

established operating level.

(3) Quarterly quality control tests. Facilities with screen-film

systems shall perform the following quality control tests at least

quarterly:

(i) Fixer retention in film. The residual fixer shall be no more

than 5 micrograms per square cm.

(ii) Repeat analysis. If the total repeat or reject rate changes

from the previously determined rate by more than 2.0 percent of the

total films included in the analysis, the reason(s) for the change

shall be determined. Any corrective actions shall be recorded and the

results of these corrective actions shall be assessed.

(4) Semiannual quality control tests. Facilities with screen-film

systems shall perform the following quality control tests at least

semiannually:

(i) Darkroom fog. The optical density attributable to darkroom fog

shall not exceed 0.05 when a mammography film of the type used in the

facility, which has a mid-density of no less than 1.2 OD, is exposed to

typical darkroom conditions for 2 minutes while such film is placed on

the counter top emulsion side up. If the darkroom has a safelight used

for mammography film, it shall be on during this test.

(ii) Screen-film contact. Testing for screen-film contact shall be

conducted using 40 mesh copper screen. All cassettes used in the

facility for mammography shall be tested.

(iii) Compression device performance. (A) A compression force of at

least 111 newtons (25 pounds) shall be provided.

(B) Effective October 28, 2002, the maximum compression force for

the initial power drive shall be between 111 newtons (25 pounds) and

209 newtons (47 pounds).

(5) Annual quality control tests. Facilities with screen-film

systems shall perform the following quality control tests at least

annually:

(i) Automatic exposure control performance. (A) The AEC shall be

capable of maintaining film optical density within 0.30 of

the mean optical density when thickness of a homogeneous material is

varied over a range of 2 to 6 cm and the kVp is varied appropriately

for such thicknesses over the kVp range used clinically in the

facility. If this requirement cannot be met, a technique chart shall be

developed showing appropriate techniques (kVp and density control

settings) for different breast thicknesses and compositions that must

be used so that optical densities within 0.30 of the

average under phototimed conditions can be produced.

(B) After October 28, 2002, the AEC shall be capable of maintaining

film optical density (OD) within 0.15 of the mean optical

density when thickness of a homogeneous material is varied over a range

of 2 to 6 cm and the kVp is varied appropriately for such thicknesses

over the kVp range used clinically in the facility.

(C) The optical density of the film in the center of the phantom

image shall not be less than 1.20.

(ii) Kilovoltage peak (kVp) accuracy and reproducibility. (A) The

kVp shall be accurate within 5 percent of the indicated or

selected kVp at:

(1) The lowest clinical kVp that can be measured by a kVp test

device;

(2) The most commonly used clinical kVp;

(3) The highest available clinical kVp, and

(B) At the most commonly used clinical settings of kVp, the

coefficient of variation of reproducibility of the kVp shall be equal

to or less than 0.02.

(iii) Focal spot condition. Until October 28, 2002, focal spot

condition shall be evaluated either by determining system resolution or

by measuring focal spot dimensions. After October 28, 2002, facilities

shall evaluate focal spot condition only by determining the system

resolution.

(A) System Resolution. (1) Each X-ray system used for mammography,

in combination with the mammography screen-film combination used in the

facility, shall provide a minimum resolution of 11 Cycles/millimeters

(mm) (line-pairs/mm) when a high contrast resolution bar test pattern

is oriented with the bars perpendicular to the anode-cathode axis, and

a minimum resolution of 13 line-pairs/mm when the bars are parallel to

that axis.

(2) The bar pattern shall be placed 4.5 cm above the breast support

surface, centered with respect to the chest wall edge of the image

receptor, and with the edge of the pattern within 1 cm of the chest

wall edge of the image receptor.

(3) When more than one target material is provided, the measurement

in paragraph (e)(5)(iii)(A) of this section shall be made using the

appropriate focal spot for each target material.

(4) When more than one SID is provided, the test shall be performed

at SID most commonly used clinically.

(5) Test kVp shall be set at the value used clinically by the

facility for a standard breast and shall be performed in the AEC mode,

if available. If necessary, a suitable absorber may be placed in the

beam to increase exposure times. The screen-film cassette combination

used by the facility shall be used to test for this requirement and

shall be placed in the normal location used for clinical procedures.

(B) Focal spot dimensions. Measured values of the focal spot length

(dimension parallel to the anode cathode axis) and width (dimension

perpendicular to the anode cathode axis) shall be within the tolerance

limits specified in Table 1.

[[Page 60628]]

Table 1

----------------------------------------------------------------------------------------------------------------

Focal Spot Tolerance Limit

-----------------------------------------------------------------------------------------------------------------

Maximum Measured Dimensions

Nominal Focal Spot Size (mm) ---------------------------------------------------------------------------

Width(mm) Length(mm)

----------------------------------------------------------------------------------------------------------------

0.10................................ 0.15 0.15

0.15................................ 0.23 0.23

0.20................................ 0.30 0.30

0.30................................ 0.45 0.65

0.40................................ 0.60 0.85

0.60................................ 0.90 1.30

----------------------------------------------------------------------------------------------------------------

(iv) Beam quality and half-value layer (HVL). The HVL shall meet

the specifications of Sec. 1020.30(m)(1) of this chapter for the

minimum HVL. These values, extrapolated to the mammographic range, are

shown in Table 2. Values not shown in Table 2 may be determined by

linear interpolation or extrapolation.

Table 2

------------------------------------------------------------------------

X-ray Tube Voltage (kilovolt peak) and Minimum HVL

-------------------------------------------------------------------------

Minimum HVL

Designed Operating Range (kV) Measured Operating (millimeters of

Voltage (kV) aluminum)

------------------------------------------------------------------------

Below 50 20 0.20

25 0.25

30 0.30

------------------------------------------------------------------------

(v) Breast entrance air kerma and AEC reproducibility. The

coefficient of variation for both air kerma and mA's shall not exceed

0.05.

(vi) Dosimetry. The average glandular dose delivered during a

single cranio-caudal view of an FDA-accepted phantom simulating a

standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per

exposure. The dose shall be determined with technique factors and

conditions used clinically for a standard breast.

(vii) X-ray field/light field/image receptor/compression paddle

alignment. (A) All systems shall have beam-limiting devices that allow

the useful X-ray beam to extend to or beyond the edges of the image

receptor but by no more than 2 percent of the SID at the chest wall

side.

(B) If a light field that passes through the X-ray beam limitation

device is provided, it shall be aligned with the X-ray field so that

the total of any misalignment of the edges of the light field and the

X-ray field along either the length or the width of the visually

defined field at the plane of the breast support surface shall not

exceed 2 percent of the SID.

(C) The chest wall edge of the compression paddle shall not extend

beyond the chest wall edge of the image receptor by more than one

percent of the SID when tested with the compression paddle placed above

the breast support surface at a distance equivalent to standard breast

thickness. The shadow of the vertical edge of the compression paddle

shall not be visible on the image.

(viii) Uniformity of screen speed. Uniformity of screen speed of

all the cassettes in the facility shall be tested and the difference

between the maximum and minimum optical densities shall not exceed

0.30. Screen artifacts shall also be evaluated during this test.

(ix) System artifacts. System artifacts shall be evaluated with a

high-grade, defect-free sheet of homogeneous material large enough to

cover the mammography cassette and shall be performed for all cassette

sizes used in the facility using a grid appropriate for the cassette

size being tested. System artifacts shall also be evaluated for all

available focal spot sizes and target filter combinations used

clinically.

(x) Radiation output. (A) The system shall be capable of producing

a minimum output of 4.5 mGy air kerma per second (513 milli Roentgen

(mR) per second) when operating at 28 kVp in the standard mammography

(moly/moly) mode at any SID where the system is designed to operate and

when measured by a detector with its center located 4.5 cm above the

breast support surface with the compression paddle in place between the

source and the detector. After October 28, 2002, the system, under the

same measuring conditions shall be capable of producing a minimum

output of 7.0 mGy air kerma per second (800 mR per second) when

operating at 28 kVp in the standard (moly/moly) mammography mode at any

SID where the system is designed to operate.

(B) The system shall be capable of maintaining the required minimum

radiation output averaged over a 3.0 second period.

(xi) Decompression. If the system is equipped with a provision for

automatic decompression after completion of an exposure or interruption

of power to the system, the system shall be tested to confirm that it

provides:

(A) An override capability to allow maintenance of compression;

(B) A continuous display of the override status; and

(C) A manual emergency compression release that can be activated in

the event of power or automatic release failure.

(6) Quality control tests--other modalities. For systems with image

receptor modalities other than screen-film, the quality assurance

program shall be substantially the same as the quality assurance

program recommended by the image receptor manufacturer, except that the

maximum allowable dose shall not exceed the maximum allowable dose for

screen-film systems in paragraph (e)(5)(vi) of this section.

(7) Mobile Units. The facility shall verify that mammography units

used to produce mammograms at more than one location meet the

requirements in paragraphs (e)(1) through (e)(6) of this section. In

addition, at each examination location, before any

[[Page 60629]]

examinations are conducted, the facility shall verify satisfactory

performance of such units using a test method that establishes the

adequacy of the image quality produced by the unit.

(8) Use of test results. (i) After completion of the tests

specified in paragraphs (e)(1) through (e)(7) of this section, the

facility shall compare the test results to the corresponding specified

action limits; or, for nonscreen-film modalities, to the manufacturer's

recommended action limits; or, for post-move, preexamination testing of

mobile units, to the limits established in the test method used by the

facility.

(ii) If the test results fall outside of the action limits, the

source of the problem shall be identified and corrective actions shall

be taken:

(A) Before any further examinations are performed or any films are

processed using the component of the mammography system that failed the

test, if the failed test was that described in paragraphs (e)(1),

(e)(2), (e)(4)(ii), (e)(4)(iii), (e)(5)(i), (e)(5)(iii), (e)(5)(v),

(e)(5)(vi), (e)(6), or (e)(7) of this section;

(B) Within 30 days of the test date for all other tests described

in paragraph (e) of this section.

(9) Surveys. (i) At least once a year, each facility shall undergo

a survey by a medical physicist or by an individual under the direct

supervision of a medical physicist. At a minimum, this survey shall

include the performance of tests to ensure that the facility meets the

quality assurance requirements of the annual tests described in

paragraphs (e)(5) and (e)(6) of this section and the weekly phantom

image quality test described in paragraph (e)(2) of this section.

(ii) The results of all tests conducted by the facility in

accordance with paragraphs (e)(1) through (e)(7) of this section, as

well as written documentation of any corrective actions taken and their

results, shall be evaluated for adequacy by the medical physicist

performing the survey.

(iii) The medical physicist shall prepare a survey report that

includes a summary of this review and recommendations for necessary

improvements.

(iv) The survey report shall be sent to the facility within 30 days

of the date of the survey.

(v) The survey report shall be dated and signed by the medical

physicist performing or supervising the survey. If the survey was

performed entirely or in part by another individual under the direct

supervision of the medical physicist, that individual and the part of

the survey that individual performed shall also be identified in the

survey report.

(10) Mammography equipment evaluations. Additional evaluations of

mammography units or image processors shall be conducted whenever a new

unit or processor is installed, a unit or processor is dissembled and

reassembled at the same or a new location, or major components of a

mammography unit or processor equipment are changed or repaired. These

evaluations shall be used to determine whether the new or changed

equipment meets the requirements of applicable standards in paragraphs

(b) and (e) of this section. All problems shall be corrected before the

new or changed equipment is put into service for examinations or film

processing. The mammography equipment evaluation shall be performed by

a medical physicist or by an individual under the direct supervision of

a medical physicist.

(11) Facility cleanliness. (i) The facility shall establish and

implement adequate protocols for maintaining darkroom, screen, and view

box cleanliness.

(ii) The facility shall document that all cleaning procedures are

performed at the frequencies specified in the protocols.

(12) Calibration of air kerma measuring instruments. Instruments

used by medical physicists in their annual survey to measure the air

kerma or air kerma rate from a mammography unit shall be calibrated at

least once every 2 years and each time the instrument is repaired. The

instrument calibration must be traceable to a national standard and

calibrated with an accuracy of 6 percent (95 percent

confidence level) in the mammography energy range.

(13) Infection control. Facilities shall establish and comply with

a system specifying procedures to be followed by the facility for

cleaning and disinfecting mammography equipment after contact with

blood or other potentially infectious materials. This system shall

specify the methods for documenting facility compliance with the

infection control procedures established and shall:

(i) Comply with all applicable Federal, State, and local

regulations pertaining to infection control; and

(ii) Comply with the manufacturer's recommended procedures for the

cleaning and disinfection of the mammography equipment used in the

facility; or

(iii) If adequate manufacturer's recommendations are not available,

comply with generally accepted guidance on infection control, until

such recommendations become available.

(f) Quality assurance-mammography medical outcomes audit. Each

facility shall establish and maintain a mammography medical outcomes

audit program to followup positive mammographic assessments and to

correlate pathology results with the interpreting physician's findings.

This program shall be designed to ensure the reliability, clarity, and

accuracy of the interpretation of mammograms.

(1) General requirements. Each facility shall establish a system to

collect and review outcome data for all mammograms performed, including

followup on the disposition of all positive mammograms and correlation

of pathology results with the interpreting physician's mammography

report. Analysis of these outcome data shall be made individually and

collectively for all interpreting physicians at the facility. In

addition, any cases of breast cancer among women imaged at the facility

that subsequently become known to the facility shall prompt the

facility to initiate followup on surgical and/or pathology results and

review of the mammograms taken prior to the diagnosis of a malignancy.

(2) Frequency of audit analysis. The facility's first audit

analysis shall be initiated no later than 12 months after the date the

facility becomes certified, or 12 months after April 28, 1999,

whichever date is the latest. This audit analysis shall be completed

within an additional 12 months to permit completion of diagnostic

procedures and data collection. Subsequent audit analyses will be

conducted at least once every 12 months.

(3) Reviewing interpreting physician. Each facility shall designate

at least one interpreting physician to review the medical outcomes

audit data at least once every 12 months. This individual shall record

the dates of the audit period(s) and shall be responsible for analyzing

results based on this audit. This individual shall also be responsible

for documenting the results, notifying other interpreting physicians of

their results and the facility aggregate results. If followup actions

are taken, the reviewing interpreting physician shall also be

responsible for documenting the nature of the followup.

(g) Mammographic procedure and techniques for mammography of

patients with breast implants. (1) Each facility shall have a procedure

to inquire whether or not the patient has breast implants prior to the

actual mammographic exam.

[[Page 60630]]

(2) Except where contraindicated, or unless modified by a

physician's directions, patients with breast implants undergoing

mammography shall have mammographic views to maximize the visualization

of breast tissue.

(h) Consumer complaint mechanism. Each facility shall:

(1) Establish a written and documented system for collecting and

resolving consumer complaints;

(2) Maintain a record of each serious complaint received by the

facility for at least 3 years from the date the complaint was received;

(3) Provide the consumer with adequate directions for filing

serious complaints with the facility's accreditation body if the

facility is unable to resolve a serious complaint to the consumer's

satisfaction;

(4) Report unresolved serious complaints to the accreditation body

in a manner and timeframe specified by the accreditation body.

(i) Clinical image quality. Clinical images produced by any

certified facility must continue to comply with the standards for

clinical image quality established by that facility's accreditation

body.

(j) Additional mammography review and patient notification. (1) If

FDA believes that mammography quality at a facility has been

compromised and may present a serious risk to human health, the

facility shall provide clinical images and other relevant information,

as specified by FDA, for review by the accreditation body or other

entity designated by FDA. This additional mammography review will help

the agency to determine whether the facility is in compliance with this

section and, if not, whether there is a need to notify affected

patients, their physicians, or the public that the reliability,

clarity, and accuracy of interpretation of mammograms has been

compromised.

(2) If FDA determines that any activity related to the provision of

mammography at a facility may present a serious risk to human health

such that patient notification is necessary, the facility shall notify

patients or their designees, their physicians, or the public of action

that may be taken to minimize the effects of the risk. Such

notification shall occur within a timeframe and in a manner specified

by FDA.

Sec. 900.13 Revocation of accreditation and revocation ofaccreditation

body approval.

(a) FDA action following revocation of accreditation. If a

facility's accreditation is revoked by an accreditation body, the

agency may conduct an investigation into the reasons for the

revocation. Following such investigation, the agency may determine that

the facility's certificate shall no longer be in effect or the agency

may take whatever other action or combination of actions will best

protect the public health, including the establishment and

implementation of a corrective plan of action that will permit the

certificate to continue in effect while the facility seeks

reaccreditation. A facility whose certificate is no longer in effect

because it has lost its accreditation may not practice mammography.

(b) Withdrawal of FDA approval of an accreditation body. (1) If FDA

withdraws approval of an accreditation body under Sec. 900.6, the

certificates of facilities previously accredited by such body shall

remain in effect for up to 1 year from the date of the withdrawal of

approval, unless FDA determines, in order to protect human health or

because the accreditation body fraudulently accredited facilities, that

the certificates of some or all of the facilities should be revoked or

suspended or that a shorter time period should be established for the

certificates to remain in effect.

(2) After 1 year from the date of withdrawal of approval of an

accreditation body, or within any shorter period of time established by

the agency, the affected facilities must obtain accreditation from

another accreditation body, or from another entity designated by FDA.

Sec. 900.14 Suspension or revocation of certificates.

(a) Except as provided in paragraph (b) of this section, FDA may

suspend or revoke a certificate if FDA finds, after providing the owner

or operator of the facility with notice and opportunity for an informal

hearing in accordance with part 16 of this chapter, that the owner,

operator, or any employee of the facility:

(1) Has been guilty of misrepresentation in obtaining the

certificate;

(2) Has failed to comply with the standards of Sec. 900.12;

(3) Has failed to comply with reasonable requests of the agency or

the accreditation body for records, information, reports, or materials

that FDA believes are necessary to determine the continued eligibility

of the facility for a certificate or continued compliance with the

standards of Sec. 900.12;

(4) Has refused a reasonable request of a duly designated FDA

inspector, State inspector, or accreditation body representative for

permission to inspect the facility or the operations and pertinent

records of the facility;

(5) Has violated or aided and abetted in the violation of any

provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or

(6) Has failed to comply with prior sanctions imposed by the agency

under 42 U.S.C. 263b(h).

(b) FDA may suspend the certificate of a facility before holding a

hearing if FDA makes a finding described in paragraph (a) of this

section and also determines that;

(1) The failure to comply with required standards presents a

serious risk to human health;

(2) The refusal to permit inspection makes immediate suspension

necessary; or

(3) There is reason to believe that the violation or aiding and

abetting of the violation was intentional or associated with fraud.

(c) If FDA suspends a certificate in accordance with paragraph (b)

of this section:

(1) The agency shall provide the facility with an opportunity for

an informal hearing under part 16 of this chapter not later than 60

days from the effective date of this suspension;

(2) The suspension shall remain in effect until the agency

determines that:

(i) Allegations of violations or misconduct were not substantiated;

(ii) Violations of required standards have been corrected to the

agency's satisfaction; or

(iii) The facility's certificate is revoked in accordance with

paragraph (d) of this section;

(d) After providing a hearing in accordance with paragraph (c)(1)

of this section, the agency may revoke the facility's certificate if

the agency determines that the facility:

(1) Is unwilling or unable to correct violations that were the

basis for suspension; or

(2) Has engaged in fraudulent activity to obtain or continue

certification.

Sec. 900.15 Appeals of adverse accreditation or reaccreditation

decisions that preclude certification or recertification.

(a) The appeals procedures described in this section are available

only for adverse accreditation or reaccreditation decisions that

preclude certification or recertification by FDA. Agency decisions to

suspend or revoke certificates that are already in effect will be

handled in accordance with Sec. 900.14.

(b) Upon learning that a facility has failed to become accredited

or reaccredited, FDA will notify the facility that the agency is unable

to certify that facility without proof of accreditation.

(c) A facility that has been denied accreditation or

reaccreditation is

[[Page 60631]]

entitled to an appeals process from the accreditation body, in

accordance with Sec. 900.7. A facility must avail itself of the

accreditation body's appeal process before requesting reconsideration

from FDA.

(d) A facility that cannot achieve satisfactory resolution of an

adverse accreditation decision through the accreditation body's appeal

process is entitled to further appeal in accordance with procedures set

forth in this section and in regulations published in 42 CFR part 498.

(1) References to the Health Care Financing Administration (HCFA)

in 42 CFR part 498 should be read as the Division of Mammography

Quality and Radiation Programs (DMQRP), Center for Devices and

Radiological Health, Food and Drug Administration.

(2) References to the Appeals Council of the Social Security

Administration in 42 CFR part 498 should be read as references to the

Departmental Appeals Board.

(3) In accordance with the procedures set forth in subpart B of 42

CFR part 498, a facility that has been denied accreditation following

appeal to the accreditation body may request reconsideration of that

adverse decision from DMQRP.

(i) A facility must request reconsideration by DMQRP within 60 days

of the accreditation body's adverse appeals decision, at the following

address: Division of Mammography Quality and Radiation Programs (HFZ-

240), Center for Devices and Radiological Health, Food and Drug

Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility

Accreditation Review Committee.

(ii) The request for reconsideration shall include three copies of

the following records:

(A) The accreditation body's original denial of accreditation.

(B) All information the facility submitted to the accreditation

body as part of the appeals process;

(C) A copy of the accreditation body's adverse appeals decision;

and

(D) A statement of the basis for the facility's disagreement with

the accreditation body's decision.

(iii) DMQRP will conduct its reconsideration in accordance with the

procedures set forth in subpart B of 42 CFR part 498.

(4) A facility that is dissatisfied with DMQRP's decision following

reconsideration is entitled to a formal hearing in accordance with

procedures set forth in subpart D of 42 CFR part 498.

(5) Either the facility or FDA may request review of the hearing

officer's decision. Such review will be conducted by the Departmental

Appeals Board in accordance with subpart E of 42 CFR part 498.

(6) A facility cannot perform mammography services while an adverse

accreditation decision is being appealed.

Sec. 900.16 Appeals of denials of certification.

(a) The appeals procedures described in this section are available

only to facilities that are denied certification by FDA after they have

been accredited by an approved accreditation body. Appeals for

facilities that have failed to become accredited are governed by the

procedures set forth in Sec. 900.15.

(b) FDA may deny the application if the agency has reason to

believe that:

(1) The facility will not be operated in accordance with standards

established under Sec. 900.12;

(2) The facility will not permit inspections or provide access to

records or information in a timely fashion; or

(3) The facility has been guilty of misrepresentation in obtaining

the accreditation.

(c)(1) If FDA denies an application for certification by a faciity

that has received accreditation from an approved accreditation body,

FDA shall provide the facility with a statement of the grounds on which

the denial is based.

(2) A facility that has been denied accreditation may request

reconsideration and appeal of FDA's determination in accordance with

the applicable provisions of Sec. 900.15(d).

Sec. 900.17 [Reserved]

Sec. 900.18 Alternative requirements for Sec. 900.12 quality

standards.

(a) Criteria for approval of alternative standards. Upon

application by a qualified party as defined in paragraph (b) of this

section, FDA may approve an alternative to a quality standard under

Sec. 900.12, when the agency determines that:

(1) The proposed alternative standard will be at least as effective

in assuring quality mammography as the standard it proposes to replace,

and

(2) The proposed alternative:

(i) Is too limited in its applicability to justify an amendment to

the standard; or

(ii) Offers an expected benefit to human health that is so great

that the time required for amending the standard would present an

unjustifiable risk to the human health; and

(3) The granting of the alternative is in keeping with the purposes

of 42 U.S.C. 263b.

(b) Applicants for alternatives. (1) Mammography facilities and

accreditation bodies may apply for alternatives to the quality

standards of Sec. 900.12.

(2) Federal agencies and State governments that are not

accreditation bodies may apply for alternatives to the standards of

Sec. 900.12(a).

(3) Manufacturers and assemblers of equipment used for mammography

may apply for alternatives to the standards of Sec. 900.12(b) and (e).

(c) Applications for approval of an alternative standard. An

application for approval of an alternative standard or for an amendment

or extension of the alternative standard shall be submitted in an

original and two copies to the Director, Division of Mammography

Quality and Radiation Programs (HFZ-240), Center for Devices and

Radiological Health, Food and Drug Administration, 1350 Piccard Dr.,

Rockville, MD 20850. The application for approval of an alternative

standard shall include the following information:

(1) Identification of the original standard for which the

alternative standard is being proposed and an explanation of why the

applicant is proposing the alternative;

(2) A description of the manner in which the alternative is

proposed to deviate from the original standard;

(3) A description, supported by data, of the advantages to be

derived from such deviation;

(4) An explanation, supported by data, of how such a deviation

would ensure equal or greater quality of production, processing, or

interpretation of mammograms than the original standard;

(5) The suggested period of time that the proposed alternative

standard would be in effect; and

(6) Such other information required by the Director to evaluate and

act on the application.

(d) Ruling on applications. (1) FDA may approve or deny, in whole

or in part, a request for approval of an alternative standard or any

amendment or extension thereof, and shall inform the applicant in

writing of this action. The written notice shall state the manner in

which the requested alternative standard differs from the agency

standard and a summary of the reasons for approval or denial of the

request. If the request is approved, the written notice shall also

include the effective date and the termination date of the approval and

a summary of the limitations and conditions attached to the approval

and any other information that may be relevant to the approved request.

Each approved alternative standard shall be assigned an identifying

number.

[[Page 60632]]

(2) Notice of an approved request for an alternative standard or

any amendment or extension thereof shall be placed in the public docket

file in the Dockets Management Branch and may also be in the form of a

notice published in the Federal Register. The notice shall state the

name of the applicant, a description of the published agency standard,

and a description of the approved alternative standard, including

limitations and conditions attached to the approval of the alternative

standard.

(3) Summaries of the approval of alternative standards, including

information on their nature and number, shall be provided to the

National Mammography Quality Assurance Advisory Committee.

(4) All applications for approval of alternative standards and for

amendments and extensions thereof and all correspondence (including

written notices of approval) on these applications shall be available

for public disclosure in the Dockets Management Branch, excluding

patient identifiers and confidential commercial information.

(e) Amendment or extension of an alternative standard. An

application for amending or extending approval of an alternative

standard shall include the following information:

(1) The approval number and the expiration date of the alternative

standard;

(2) The amendment or extension requested and the basis for the

amendment or extension; and

(3) An explanation, supported by data, of how such an amendment or

extension would ensure equal or greater quality of production,

processing, or interpretation of mammograms than the original standard.

(f) Applicability of the alternative standards. (1) Except as

provided in paragraphs (f)(2) and (f)(3) of this section, any approval

of an alternative standard, amendment, or extension may be implemented

only by the entity to which it was granted and under the terms under

which it was granted. Other entities interested in similar or identical

approvals must file their own application following the procedures of

paragraph (c) of this section.

(2) When an alternative standard is approved for a manufacturer of

equipment, any facility using that equipment will also be covered by

the alternative standard.

(3) The agency may extend the alternative standard to other

entities when FDA determines that expansion of the approval of the

alternative standard would be an effective means of promoting the

acceptance of measures to improve the quality of mammography. All such

determinations will be publicized by appropriate means.

(g) Withdrawal of approval of alternative requirements. FDA shall

amend or withdraw approval of an alternative standard whenever the

agency determines that this action is necessary to protect the human

health or otherwise is justified by Sec. 900.12. Such action will

become effective on the date specified in the written notice of the

action sent to the applicant, except that it will become effective

immediately upon notification of the applicant when FDA determines that

such action is necessary to prevent an imminent health hazard.

Dated: November 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-29596 Filed 11-6-97; 1:07 pm]

BILLING CODE 4160-01-F