60614 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 900

[Docket No. 95N–0192]

RIN 0910–AA24

Quality Mammography Standards;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; 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 § 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, ‘‘§ 716.1’’ is corrected to read

‘‘§ 16.1’’.

§ 900.3 [Corrected]

14. On page 55979, in the second

column in § 900.3(c)(4), a comma is

inserted after ‘‘July 28, 1998’’.

§ 900.12 [Corrected]

15. On page 55986, in the first

column, in the introductory text of

§ 900.12(a)(2)(iv), a comma is inserted

after ‘‘October 28, 1997’’.

16. On page 55987, in the second

column, in § 900.12(b)(6)(ii) the word

‘‘valve’’ is corrected to read ‘‘value’’; in

§ 900.12(b)(8)(i), ‘‘October 28, 1999’’ is

corrected to read ‘‘October 28, 2002’’.

17. On page 55989, in the first

column, in § 900.12(e)(1)(ii), (iii),

(e)(2)(ii), and (e)(5)(ii) the ‘‘+’’ sign is

corrected to read ‘‘±’’; and in

§ 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 § 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 § 900.12(e)(12) the ‘‘+’’ sign

is corrected to read ‘‘±’’.

20. On page 55992, in the heading for

§ 900.12(h), the word ‘‘compliant’’ is

corrected to read ‘‘complaint’’.

§ 900.18 [Corrected]

21. On page 55993, in § 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

§ 900.12 quality standards.

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

42 U.S.C. 263b.

Subpart A—Accreditation

§ 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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 60615

not apply to facilities of the Department

of Veterans Affairs.

§ 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 § 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

§ 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 § 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 § 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

§ 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 § 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
60616 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

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 § 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

§ 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

§ 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 § 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 § 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.

§ 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 § 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 § 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 § 900.4(c), random clinical image

reviews in accordance with § 900.4(f),

and additional mammography review in

accordance with § 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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 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 § 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 § 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 § 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 § 900.3(b)(1), three copies of

a renewal application containing the

information, materials, and supporting

documentation requested by FDA in

accordance with § 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

§ 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.

§ 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

§ 900.3(d) or paragraph (a)(8) of this

section. Such quality assurance program

shall:
60618 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

(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 § 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 § 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

§ 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

§ 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 § 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 § 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 § 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.
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 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

§ 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 § 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 § 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

§ 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

§ 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

§ 900.12(a)(3) or alternative

requirements established by the

accreditation body and approved by

FDA in accordance with § 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 § 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;
60620 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

(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 § 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

§ 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 § 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 with§ 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 § 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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 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.

§ 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 § 900.6.

§ 900.6 Withdrawal of approval.

If FDA determines, through the

evaluation activities of § 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.

§ 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 § 900.3(d) or

§ 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 § 900.15.

§§ 900.8—900.9 [Reserved]

Subpart B—Quality Standards and

Certification

§ 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.

§ 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 § 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
60622 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

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

§ 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 § 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.

§ 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 multireading 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,
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 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
60624 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

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 §§ 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

§ 1020.31(f)(3) of this chapter.

(2) General. All radiographic

equipment used for mammography shall
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 60625

be specifically designed for

mammography and shall be certified

pursuant to § 1010.2 of this chapter as

meeting the applicable requirements of

§§ 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 targetfilter 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:
60626 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

(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 § 900.3(b) or

§ 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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 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 § 900.3(d) or

§ 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.
60628 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

TABLE 1

Focal Spot Tolerance Limit

Nominal Focal Spot Size (mm)

Maximum Measured Dimensions

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 § 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

Designed Operating Range (kV) Measured Operating

Voltage (kV)

Minimum HVL (millimeters of 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 craniocaudal 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 beamlimiting devices that allow the useful Xray 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 Xray 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 screenfilm, 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 screenfilm 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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 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.
60630 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

(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.

§ 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 § 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.

§ 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 § 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 § 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.

§ 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 § 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
Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations 60631

entitled to an appeals process from the

accreditation body, in accordance with

§ 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.

§ 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 § 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 § 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 § 900.15(d).

§ 900.17 [Reserved]

§ 900.18 Alternative requirements for

§ 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

§ 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

§ 900.12.

(2) Federal agencies and State

governments that are not accreditation

bodies may apply for alternatives to the

standards of § 900.12(a).

(3) Manufacturers and assemblers of

equipment used for mammography may

apply for alternatives to the standards of

§ 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.
60632 Federal Register / Vol. 62, No. 217 / Monday, November 10, 1997 / Rules and Regulations

(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 § 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