+--------------------------------+-----------------+-------------------+
| SUBJECT:                       |                 | IMPLEMENTATION    |
|                                |                 | DATE              |
| Field Compliance Testing of    |                 |                   |
| Diagnostic (Medical)           |                 | October 1, 2000   |
|                                |                 |                   |
| X-ray Equipment                |                 |                   |
+--------------------------------+-----------------+-------------------+
|                                |                 | COMPLETION DATE   |
|                                |                 |                   |
|                                |                 | September 30,     |
|                                |                 | 2003              |
+--------------------------------+-----------------+-------------------+
| **DATA REPORTING**             |                 |                   |
+--------------------------------+-----------------+-------------------+
| **PRODUCT CODES**              | **PRO           |                   |
|                                | DUCT/ASSIGNMENT |                   |
|                                | CODES**         |                   |
+--------------------------------+-----------------+-------------------+
| 90IZF 90IZL 90KPR              | 86003           |                   |
|                                |                 |                   |
| 90IZG 90 JAA                   |                 |                   |
|                                |                 |                   |
| 90IZH 90JAB                    |                 |                   |
|                                |                 |                   |
| 90IZI 90 JAC                   |                 |                   |
|                                |                 |                   |
| 90IZJ 90KPQ                    |                 |                   |
+--------------------------------+-----------------+-------------------+

[FIELD REPORTING REQUIREMENTS]{.underline}

A. GENERAL

[Routine Compliance Tests]{.underline} ‑ Subsequent to accomplishing
district auditor review, the auditor will distribute Field Test Record
forms as follows:

‑ Original (White Copy) . . . . . . Information Processing and Office
Automation HFZ-307

‑ 1st (White Copy) . . . . . . . . . . Home district auditor for review
and filing

‑ Blue Copy . . . . . . . . . . . . . . Regional Radological Health
Representative (RRHR) for State file

The following field test records shall be handled in the above manner
with order of priority as listed below:

FDA 3071 General Information

FDA 2784 Abovetable X-ray Source Radiographic Systems

FDA 2786 Undertable X-ray Source Fluoroscopic and Spot Film Systems

FDA 3068 Peak Kilovoltage Determination

FDA 3260 C‑Arm Fluoroscopic and Spot Film Systems

FDA 3069 Abovetable X-ray Source Fluoroscopic and Spot Film Systems

FDA 3261 Vertically Mounted Cassette Holder Radiographic Systems

FDA 2783 Mobile Radiographic Systems

FDA 3297 Head and Neck Radiographic Systems

FDA 2785 Dental Radiographic Systems

FDA 3070 Mammographic Systems

FDA 2782 Field Test Record Continuation Sheet

-   Beginning October 1, 1994, routine compliance testing of
    mammographic equipment will not be conducted by this compliance
    program unless approved under special consideration by the RRHR. The
    RRHR will contact the Center for Devices and Radiological Health
    (CDRH) to receive authorization for such tests. In addition testing
    of dental units will not be conducted routinely. The RRHR must be
    contacted to approve special testing for dental units.

-   The Home District will verify corrections, review the CDRH status
    report of the Field Correction Action Report (FCAR) and ensure
    updates have been added to the CDRH computer. The Home District will
    also review incorrect or incomplete Reports of Assembly FDA 2579,
    obtain any necessary corrections from the assembler, and notify
    HFZ-307 of corrections.

Submit all violative assembler inspection reports to the District
Compliance Branch for review, evaluation, and classification prior to
referral to CDRH, Division of Program Operations, HFZ-305. Do not send
non-actionable inspection reports to HFZ-305.

B. FACTS REPORTING

-   The rules for what activities should be reported under each of the
    operation codes has not changed with the implementation of FACTS
    V.2. Therefore, the following guidelines should continue to be used:

-   Report all time spent in reviewing and correcting FDA 2579s (Reports
    of Assembly) under Operation Code 13 (Investigations) in the FACTS
    "Maintain Investigations" screen. Time spent in correspondence
    (verbal/written) regarding FDA-2579s should be reported under this
    operation code also.

Report all time spent in preparation, arranging the test, and on-site
conducting of field tests under Operation Code 53 (Field
Examination/Test) in the FACTS "Maintain Field Examination/Tests" screen
since the test is an inspection of the assembler's performance. Enter
the number of tests performed for the assembler on that date and also
reference the field test record (FTR) number(s) in the description
field.

[SPECIAL AUDITOR INSTRUCTIONS]{.underline}: When performing an on-site
audit of an x-ray surveyor, a special entry must be made in FACTS. Time
shall be reported as a field test (Operation Code 53) and includes
preparation time, on-site time, test evaluation time, and audit result
reporting time. In the Description Field, enter the words \"Joint Test\"
followed by the code for the State or FDA District of the individual
being audited. Enter also the GI test ID for the test which was

conducted.

Example: Joint Test NJ GI12344

Joint Test DET GI12345

\* Also, report as Operation Code 92, (Coordination/Technical Review) in
the FACTS "Miscellaneous Operations Accomplishment Hours" screen time
spent as an Auditor for Field Test Record (FTR) review, Notification
Letter or Warning Letter correspondence, FCAR submissions and updating
of CDRH database, FTR data entry, FTR computer updating, and response to
FTR questions of compliance. The description field should list
"Diagnostic X-ray Coordination". Time should be reported on a routine
basis (weekly or quarterly depending on the volume) and may be combined
for that time period. \*

C. SPECIAL

Special procedures for reporting field tests are necessary when an x-ray
system or component does not comply with the Federal standard. These
procedures are detailed under the Operation Instructions of Part III
A.1.d.7 & 8.

Special Compliance Tests - A data format for reporting special tests to
the Diagnostic Devices Branch (HFZ-322) will be provided by CDRH on
assignment.

\* Report newly identified assembler firms to CDRH, HFZ-307 by returning
photo copies of assembler forms or submitting inspection reports and
indicating in large red letters, in the upper left corner, the words
\"NEW ASSEMBLER\" with their FEI number.

Send copies of all correspondence generated under this program to
HFZ-322. This includes Warning Letters, Untitled Letters, assembler\'s
response when the response is a disputed noncompliance, and assembler's
response where the assembler claims the original equipment manufacturer
is responsible for the noncompliance. Include all evidence to support
the allegation of manufacturer responsibility. \*

[PART I - BACKGROUND]{.underline}

The Diagnostic X-ray Performance Standard (Reference 1) was promulgated
in August 1974 to protect the public from unnecessary radiation hazards
of diagnostic x-ray equipment. Since 1974, FDA and State personnel have
conducted over 65,000 field tests of certified diagnostic x-ray systems
for compliance with the standard.

The most prevalent items of major noncompliance identified under this
program have been:

‑ Inoperable radiographic positive beam limitation (PBL) collimation
systems.

‑ Excessive mis-sizing of the x-ray beam by the PBL system.

‑ Excessive fluoroscopic entrance exposure rate.

‑ Excessive misalignment of the fluoroscopic x-ray field with the image
intensifier.

‑ Excessive misalignment of the x-ray field with the spot film image
receptor.

‑ Failure of the primary protective barrier interlock for fluoroscopic
systems.

‑ Insufficient illuminance of the light localizer for radiographic
collimators.

These noncompliances also represent some of the most significant
radiation hazards.

The highest rates of noncompliant systems (i.e., systems with one or
more major noncompliances) have been for the more complex radiographic
and fluoroscopic x-ray systems that require considerable calibration and
adjustment by the assembler. Mobile and dental x-ray systems that
require comparatively little adjustment by the assembler have had much
lower rates of noncompliance.

Where field testing has identified generic or design related
noncompliances, CDRH has required component manufacturers to initiate
recalls to correct violative products. Since 1974, more than 60 such
recalls have been initiated based in whole, or in part on field
activities under this compliance program. The majority of the
noncompliances identified through this program have been caused by
incomplete or improper installations by x-ray assemblers. The initial
reduction in noncompliance has come primarily from voluntary efforts by
the x-ray industry to better train and equip assemblers and to require
final system compliance testing. A stronger regulatory approach is
necessary to prevent continued violative installations and to further
reduce the noncompliance rate.

Notification letters are issued to assemblers each time a noncompliance
is discovered by routine compliance field testing. The notification
letter advises the assembler about each noncompliance and requests
corrections on a case-by-case basis without requiring any formal recall
or corrective action plan. When the assembler continues a pattern of
violative assemblies, or refuses to correct cited violations, regulatory
action (civil penalties and/or injunction) can be initiated. The
documentation and inspections necessary for civil penalty/injunction
action can be time consuming and resource intensive on FDA and,
therefore, an optional strategy has been devised which may be used
separately or in conjunction with civil penalties and/or injunction.
This additional strategy is a warning letter of declaration of assembler
noncompliance with district ordered assembler recall (NC/DOAR). By this
process, the assembler\'s installation program is considered
noncompliant by FDA. Since an assembler is considered a manufacturer
under Subchapter J Part 1000.3(n), all regulations pertaining to
noncompliance declarations pertain to assemblers. This process will
require the assembler to submit a formal corrective action plan (CAP)
and initiate a recall. Should the assembler fail to comply with the
NC/DOAR provisions, additional civil penalties can be charged for
failure to notify and correct, (Section 538(a)(2).

Previously civil penalties could only be charged for systems for which
FDA had field test data or documentation. The noncompliance declaration
process includes all assemblies during the specified time applicable to
the data analysis and will require the assembler to provide a CAP for
all of them. Thus for failure to respond or inadequate response to the
NC/DOAR, the assembler faces a greater number of violative charges than
initially using the direct civil penalty approach.

Since this strategy is based on a sample of systems installed by the
assembler, civil penalties will still be the choice of enforcement
strategy for companies installing small numbers of systems.

[PART II ‑ IMPLEMENTATION]{.underline}

A. [Objectives]{.underline}

This is a continuing, non-statistical compliance program intended:

1\. To identify certified diagnostic x-ray systems that fail to comply
with applicable performance standard requirements.

2\. To obtain correction of noncompliant systems identified in (1)
above.

3\. To identify assemblers and manufacturers responsible for violative
x-ray installations and take appropriate administrative/enforcement
actions necessary to prevent further installations of noncompliant
products.

This program is based primarily on monitoring of assembler certification
reports (FDA 2579\'s) to identify installation sites, and on field
testing (by FDA and State personnel) of x-ray systems at the user site.
Inspections of assembler firms are intended primarily as follow‑up to
violations identified from field testing and FDA 2579 reviews, and to
document reporting violations and to support legal action
recommendations.

B. [Program Management Instruction]{.underline}

1\. [Resource Instructions]{.underline}

District office interface with the automated data systems maintained by
CDRH and the role of the x-ray auditor are critical factors for
effective implementation of this program. All District Offices have
direct entry capability of field test data into the CDRH data base and
are responsible for timely data entry. Contact CDRH with any direct data
entry problems. (See Attachment B).

The accomplishing district auditor is responsible for maintaining the
competence of personnel to perform work under this program. These and
other x-ray auditor functions are described in Part III.A.2. [Only
personnel qualified under Field Management Directive No. 125 may perform
the auditor functions]{.underline} (see Attachment O). Districts without
a qualified auditor must arrange with the regional office for an auditor
from another district to perform their audit functions until a local
district auditor can be qualified. OJT may be used to assist in training
for the auditor position.

All field tests of diagnostic x-ray equipment shall be performed in
accordance with test procedures provided by the CDRH in FDA publication
number 81-8161 (Reference 4) with latest updates. Only field
investigators with specialized training may perform x-ray field tests.
Such training may consist of a formal course in x-ray survey techniques
or in‑house training arranged by the RRHR, but must include
approximately two weeks of OJT with a qualified auditor.

All FDA personnel performing or participating in field tests shall wear
personnel dosimeters issued by the Field Health Physicist at WEAC. State
personnel will utilize the personnel dosimeter normally provided by
their State program.

CDRH requires direct field test data entry using XRAYAPSY and strongly
supports on-line interactive computer access for all Districts. CDRH
provides routine and/or special reports (on request) in support of this
compliance program. Information concerning potential test locations,
assembler noncompliance trends, and assembler reporting are accessible
and should be requested through the x-ray auditor.

2\. [Planning Instructions]{.underline}

Each District shall develop a strategy:

a\. to concentrate proportionately more field testing and special
monitoring for those assemblers with the highest volume of noncompliant
installations and the highest rates of noncompliance (i.e., greatest
negative public health impact) and those assemblers suspected of
non-reporting installations and,

b\. where necessary, to develop legal action cases in accordance with
CPG 7133.12, to bring these violative assemblers into compliance.

\* For assemblers that make installations outside their home district,
the FDA home district and accomplishing district must establish a strong
liaison to monitor the assembler and develop evidence. The FDA
accomplishing district will prepare and issue all untitled letters,
review responses to the untitled letters, and update the FCAR database
for these responses. The FDA home district will prepare all warning
letters and regulatory action above an untitled letter. The FDA home
district will review the responses to warning letters and update the
FCAR database for these responses. \*

For Districts with state contract or partnership testing, the District
office will work through the RRHR to have state testing concentrate on
problem assemblers when appropriate. (Refer to Part II, B.5. ‑ RRHR
Management Activities).

Field test priorities are:

\(1\) Problem assemblers with the highest noncompliance rate as
identified by routine reports from CDRH.

\(2\) Other problem assemblers known to the district.

\(3\) High volume assemblers of radiographic and fluoroscopic systems
for whom very few systems have been tested.

\(4\) New assemblers of radiographic and fluoroscopic systems.

\(5\) Routine testing of randomly selected radiographic and fluoroscopic
systems.

\(6\) Infrequent testing of dental and mobile x-ray systems, for
training purposes or at the request of CDRH. Mammographic equipment will
not be tested under this program except under authorization from CDRH.
The MQSA testing program will cover mammographic equipment.

3\. [Legal Action Case Development]{.underline}

The primary enforcement mechanism against x-ray assemblers is Civil
Penalties with an alternative enforcement mechanism of noncompliance
declaration with district or region ordered assembler recall (NC/DOAR).
Compliance Policy Guides 7133.12 (with revised alternative enforcement)
and 7133.23 and Regulatory Procedures Manual (RPM) Chapter 6 provide
guidance for developing case recommendations. Although the RPM points
out that a health hazard is implicit in all performance standard
violations, at this time actions will be approved only for those field
tests which demonstrate more than a minimal health hazard (see
Attachment D). Should violations continue, following the assembler\'s
NC/DOAR warning, or imposition of Civil Penalties, further action (i.e.,
injunction with further Civil Penalties) will be considered.

Unlike some FDA programs where the need for legal action may be
triggered by a [single]{.underline} violative inspection report or
sample, legal action against x-ray assemblers is most frequently
triggered by a [pattern]{.underline} of violative field tests. Such a
pattern of violation cannot routinely be detected by monitoring
individual field tests or Notification letters. Special district
record-keeping or use of the CDRH computer data base by the x-ray
auditor will be needed for monitoring assembler noncompliance trends.

Recommendations for NC/DOAR warning letters will be reviewed by CDRH
(HFZ-322). For assemblers installing less than 16 systems in the cited
time frame (not to exceed two (2) years) civil penalties will be the
enforcement choice when the conditions of CPG 7133.12 are met. Table 1,
listed below will be used as criteria for noncompliance declarations.

[TABLE I]{.underline}

[No. Installed]{.underline} [No. Tested]{.underline} [No.
Noncompliant]{.underline} [%NC]{.underline}

Less than 16 (refer to CPG 7133.12 paragraph B)

16 to 25 5 2 or more 40

26 to 50 8 3 or more 37.5

51 to 90 13 4 or more 30.8

91 to 150 20 6 or more 30

151 to 280 32 8 or more 25

If the number tested exceeds the numbers listed in Table I, then the
noncompliance rate must equal or exceed the percent NC rate listed in
the table above. Should the number tested exceed 50 percent of the
number installed, Civil Penalties may be the more advantageous approach.
Any questions concerning this guidance should be referred to the
Diagnostic Devices Branch.

4\. [Inspection Priorities]{.underline}

Inspections of diagnostic x-ray assemblers shall be initiated for the
following reasons:

‑ To document the number and location of systems requiring coverage
under the firm\'s corrective action plan (CAP) when noncompliance
declaration has been issued.

‑ When preparing a civil penalty action against an assembler, to
document responsibility for violations.

‑ To obtain a listing of recent installations of certified x-ray
equipment for further testing when developing a civil penalty case.

‑ When investigating product defects or accidental radiation
occurrences.

‑ When investigating a failure to file an assembler report, form FDA
2579.

‑ When assembler reports, forms FDA 2579, are repeatedly late or
repeatedly contain critical errors.

5\. [RRHR Management Activities]{.underline}

The RRHR will coordinate and supervise voluntary working agreements and
agency contracts with states performing diagnostic x-ray field testing
including:

‑ Arrange for states to submit the test data to the district auditor for
review, calculations, and classification in accordance with Part III
A.1.f.

‑ Arrange for states to contact the auditor by phone for
[all]{.underline} Class A deficiencies as soon as possible.

‑ Review any problem reported on the \"blue copy\" of the test form by
the auditor and refer to the affected state, as appropriate.

‑ Maintain the \"blue copy\" of the test form in the state file.

‑ Draft, renew, or provide changes to Partnership Agreements (PA) for
Regional Food and Drug Director (RFDD) signature. Recommendations will
be provided to Division of Federal State Relations HFC-150 and HFZ-322.
Copies of final signed agreements will also be provided to HFC-150 and
HFZ-322. Field tests that do not pass the FDA audit will not be credited
toward the agreement number.

‑ On request from the District Office, arrange with contract or
partnership states to emphasize testing of installations by problem
assemblers identified to them by FDA and to expedite submission of test
results for those assemblers to assure timely follow-up action by FDA.

‑ Arrange for State follow-up field testing where State field test
reports have determined that violative x-ray systems require correction
and the district is unable to perform the required follow-up.

‑ Arrange for State follow-up of noncompliant x-ray systems that are
determined to be the user\'s responsibility. If a State is unable to
have the user correct a Class A timer non-termination violation, the
RRHR shall arrange for district follow-up to document the violation for
possible detention/seizure consideration.

‑ Arrange for qualified auditors to train State and FDA personnel to
perform routine field tests.

‑ Arrange with the auditor for periodic joint field test audits of State
or FDA personnel by a qualified auditor to insure that proper procedures
and techniques are used in the collection of test data.

[PART III ‑ INSPECTIONAL]{.underline}

A. OPERATIONS

1\. [Field Testing]{.underline}

a\. Test new fully certified x-ray systems, preferably within 3 months
of and not later than 1 year after installation in accordance with
specified CDRH test procedures (Reference 4).

b\. Select test sites (concentrating on problem assemblers) based on
information from:

\(1\) CDRH computer data base

\(2\) Copies of FDA 2579s sent to the district or State agency.

\(3\) Fully certified systems encountered at user facilities.

c\. Schedule appointments in advance to insure availability of the x-ray
system for testing. Arrange to have someone familiar with the x-ray
system available to assist in its operation during the test.

d\. At the test site:

\(1\) Wear personnel dosimeters (TLD badges) when performing tests.

\(2\) Issue a FDA 482 [only]{.underline} when requested by the user.
(Applies to FDA personnel only).

\(3\) Visually verify that the system is fully certified. If not fully
certified, testing may only be performed if a major component is
certified.

\(4\) Conduct the field test and complete the appropriate field test
record (FTR) as instructed in FDA 81‑8161.

\(5\) Document any x-ray system damage (real or claimed) due to the
field test on form FD 2766, Claim for Damage to an Electronic Product.
(Refer to Attachment F). Forward this form immediately through the RRHR
to Office of Compliance HFZ-300 (Do not delay submission or attempt to
refute the claimed damages).

NOTE: State survey personnel should immediately report damage to an
x-ray system to the RRHR. The RRHR will determine what follow‑up is
required.

\(6\) Review the field test record for obvious items of noncompliance
prior to leaving the test site. Class A items should be easily detected
since most represent observations by the surveyor:

‑ Primary barrier interlock failure

‑ Timer non-termination

‑ Excessive entrance exposure rate (in excess of 25 R/Min)

‑ The primary beam extends beyond the edges of the primary protective
barrier.

Attachment D provides the criteria for classifying items of
noncompliance.

\(7\) For suspected Class A violations :

\(a\) -Advise the user immediately of the results and that:

\- Routine use of the system should be discontinued until the problem is
corrected.

‑ Operation of the system could be hazardous to the patient and/or
operator.

‑ FDA will determine responsibility, notify the responsible party and
the State, and effect correction.

\(b\) Telephone the auditor immediately and inform the auditor of the
Class A condition.

\(8\) For suspected Class B violations advise the user of the results
and that:

\(a\) The system may not comply with the Federal performance standard.

\(b\) FDA will confirm the compliance status of the system via computer
data analysis.

\(c\) FDA will determine the responsibility for any items of
noncompliance, notify the responsible party, and effect correction.

\(9\) For suspected Class C results, advise the user that computer
calculations must be made to determine if the system is in compliance,
and that:

\(a\) FDA will determine the compliance status of the system.

\(b\) If the system fails to comply, FDA will determine responsibility,
notify the responsible party, and effect correction.

\(c\) FDA will send the facility a copy of any Notification letter which
it issues.

\(10\) For suspected Class D results, advise the user that while
computer calculations must be performed to determine compliance, the
system appears to be fully compliant.

\(11\) Attempt to determine responsibility for any noncompliances before
leaving the facility. (See Attachment [N]{.underline} for further
guidance).

e\. Flag suspected Class A and Class B test records. A
\"[SPECIAL]{.underline}\" sticker should be affixed to the upper left
corner of Class A test records to alert the auditor that the record has
a suspected Class A result. A route slip or other suitable identifier
with the designation \"Class B\" will suffice for suspected Class B
results.

\* f. Route suspected Class A test records to the FDA accomplishing
district auditor immediately, route suspected Class B records within 2
working days to the FDA accomplishing district auditor, and route Class
C or D records within 2 weeks after testing to the FDA accomplishing
district auditor. Send the original, 1st copy, and blue copy to the
accomplishing district auditor. Retain the yellow copy as a reference in
the event the auditor has questions regarding the field test. \*

2\. [Auditor Activities]{.underline}

a\. [Quality Assurance Review]{.underline}

The accomplishing district auditor shall:

\(1\) Ensure test data integrity by verifying the field test edit checks
as specified in the CDRH test procedures manual (Reference 4).

\(2\) Be responsible for timely field test data entry utilizing the
XRAYAPSY system for CDRH computer calculation of test results.

\(3\) Review all calculated field test results from CDRH computer entry
and,

‑ Return rejected FDA tests to the investigator\'s supervisor for
appropriate action.

‑ Return rejected state tests through the RRHR to the state. The RRHR
will work with the state to achieve acceptable tests. Rejected tests
will not count toward the state's agreement numbers.

\(4\) Classify all field test records in accordance with criteria in
Attachment D, based on test results.

\* (5) When the auditing of the record is completed and the FTR is Class
A, FAX a copy of the FTR to the FDA home district auditor and notify the
home district auditor of the Class A FTR by e-mail. The home district
auditor will prepare and send a Warning Letter. If the FTR is Class B,
the accomplishing district auditor will prepare and send an untitled
letter to the assembler regardless of the assembler's home district. For
Class B violations the accomplishing district auditor will follow-up and
assure computer update of field corrective action reporting (FCAR). \*

b\. [Evidence Development]{.underline}

The home district auditor shall:

\(1\) Make a thorough determination of responsibility for violations
when recommendations for regulatory follow‑up involving an assembler is
being considered. This determination shall include at a minimum, the
evaluation of all of the following factors which may be pertinent:

‑ field test data and calculated results

‑ responses to any Notification/user letters

‑ type of repair made to correct the violation

(adjustment vs. component replacement)

‑ equipment maintenance schedule and maintenance history

‑ all past service repair records

‑ information gathered during assembler establishment inspections

Unless there is clear documentary evidence which demonstrates that
violations are attributable to improper assembly, the assembler cannot
be held responsible.

If the service report shows only adjustment of a component, there is
presumed evidence of assembler error at installation. However,
replacement of a defective component may indicate a manufacturer problem
and is less convincing evidence of assembler responsibility. Additional
evidence development by the auditor or by CDRH engineers may be
necessary.

\(2\) Ensure that all field corrective actions of the home district are
added to the CDRH data base with proper responsible party determination.

\* (3) Request assistance from the accomplishing district auditors in
developing documentation and evidence needed for regulatory follow‑up.
\*

\(4\) Monitor field testing results, responses to Notification or
Warning Letters, assembler EI\'s, follow‑up field test data, etc., and
identify assemblers for whom recommendations for regulatory follow‑up
should be considered. The auditor will prepare a referral memo
describing the violations, evidence, and recommendation for appropriate
action of civil penalty and/or assembler recall based on criteria
specified in Part II.3 and CPG 7133.12.

\(5\) Review all Notification or Warning letters for completeness and
accuracy prior to issuance.

c\. [Quality Assurance Audits]{.underline}

‑ Perform on site quality assurance audits of FDA and State personnel to
assure their proficiency in conducting field tests of diagnostic x-ray
units.

‑ Each fiscal year, conduct at least two joint audits per person. Only
personnel conducting at least 10 field tests per year will be joint
audited. (See Field Management Directive No. 76 for further guidance).
Audits shall be:

‑ Joint field tests with the person being audited, or

‑ Follow‑up retest of the same unit within 30 days of the initial test
by the person being audited.

d\. [Training]{.underline}

Provide on‑the‑job training (OJT) for all new FDA and State surveyors
consisting of the following number of x-ray field tests:

-   NOTE: More than one person's name may appear on the field test
    record, however, the first name is the lead surveyor receiving
    credit for the survey.

    Abovetable X-ray Source Radiographic and kVp (at least 3).

    Undertable X-ray Source Fluoroscopic and Spot Film (at least 3).

    C‑Arm Fluoroscopic (at least 1).

    Mobile (at least 1).

Prior to conducting the OJT, ensure that the trainee has viewed the CDRH
videotapes on field test procedures.

e\. [Public Liaison]{.underline}

Deliver presentations, when requested, on aspects of the Diagnostic
X-ray Standard before groups of radiation professionals such as
radiologists, technologists, and physicists.

3\. [Review/Maintenance of FDA 2579, Report of Assembly of a Diagnostic
(Medical) X-ray System]{.underline}

The home district of the assembler shall:

a\. Maintain all originals of forms FDA 2579 for 3 years.

b\. When there is evidence of a problematic assembler, in preparation
for assembler inspection for cause, review FDA 2579 reports for errors.
Items requiring correction should be indicated for discussion upon
inspection.

\(1\) [Minor Corrections]{.underline} involve items not affecting
compliance (e.g., missing or incorrect date of assembly (block 3e) or
incorrect identification of component model numbers) and can be
corrected directly on the form after verification by assembler.

‑ Make the correction in red ink.

‑ Date and initial the form in the upper right hand corner.

\(2\) [Major corrections]{.underline} involve:

‑ Failure of assembler to sign the form.

‑ Failure to enter the facility name, city, or state (block 1);

> \- No indication of what components were installed (blocks 4g and 4h).

c\. For major corrections to the assembler form, have the assembler fill
out a new form with instructions to:

\- Complete the entire form.

\- Return the white original to the district.

\- Distribute the other copies as usual within 15 days.

> \- Indicate in the comments the form is a replacement for corrections
> to the original assembler form with number xxxx.

d\. Upon receipt of a replacement original form from the assembler,
review the white original. If it is correct:

‑ Initial and date the form in the upper right hand corner.

‑ Place a red sticker at the top of the white original, indicating the
accession number of the old duplicate form. (This step is crucial in
order for CDRH to locate and delete old duplicate information from the
database.)

‑ Send the original to CDRH, HFZ-307 (CDRH will update the computer
database and send the white original on to the appropriate installation
district.)

e.  For minor assembler form corrections:

-   forward a copy of the form to CDRH HFZ-307

-   indicate the corrections in red

-   place a note or sticker to indicate the form has corrections.

The installation (accomplishing) district shall:

a\. Maintain all originals of forms FDA 2579 for 1 year from date of
installation for the purpose of selecting testing sites. After 1 year
the form should be mailed to the assembler home district if it differs
from the installation district, where it will be kept for 3 years after
installation.

\* b. When a field test is conducted at an installation, attach the
original copy of FDA 2579 to the home district copy of all field test
records. After the field test record has passed the audit/edit criteria
distribute the field test record with attached FDA 2579 to the
appropriate home district office. For Class B field tests, the documents
are forwarded to the home district auditor after the FCAR has resolved
all violations. \*

[NOTE]{.underline}: For assembler reports of Dental x-ray equipment, the
assembler shall mail the original white copy of the assembler report
directly to the FDA district responsible for the installation site.

Any dental forms erroneously mailed by the assembler to CDRH will be
forwarded to the installation district. Likewise, districts should
forward to the correct [installation]{.underline} district any forms
erroneously received in their office. CDRH does not maintain assembler
forms for dental systems in the centralized data base.

All x-ray assembly reports will continue to be maintained by the
responsible home district office for at least 3 years.

4\. [Assembler Inspections]{.underline}

Conduct inspections in accordance with Chapter 5 of the IOM and
investigate these specific aspects of the assembler\'s operation:

a\. Assembly and sales records ‑ full review to determine if all
installations have been reported.

b\. Complaint files ‑ look for evidence of accidental radiation
occurrences, radiation defects, and noncompliances with the standard.

c\. Repair records ‑ determine if the assembler is charging users to
correct items of noncompliance.

d\. Test equipment and calibration ‑ assembly of noncompliant systems
may be due to use of improper test equipment or equipment which is out
of calibration.

e\. If the inspection is a follow‑up to errors or non‑submission of
forms FDA 2579:

‑ discuss the reporting requirements with the assembler.

‑ explain how to complete the forms correctly.

‑ point out discrepancies encountered on the forms and leave copies for
correction.

‑ instruct the assembler to resubmit corrected forms to the district
within 10 days.

f\. Determine responsibility for field test noncompliances by the review
of installation and repair records.

5\. [Sample Collection]{.underline} ‑ Collect documentary samples when
noncompliance is suspected and documentary evidence is needed to support
regulatory action. (see IOM 405.2). No physical samples will be
collected under this program.

B. [REPORTING BY THE ACCOMPLISHING DISTRICT AUDITOR]{.underline}

1\. [Suspected Class A Violative Field Tests]{.underline}

a\. Confirm the suspected noncompliance is a Class A violation by
consulting Attachment D of this compliance program.

b\. Verify proper user notification by the surveyor, and if not done,
immediately warn the user against use of the hazardous system.

c\. If the assembler is suspected to be responsible for the violation,
inform the assembler of the noncompliance by telephone and request
correction. Document assembler notification.

\* d. Notify CDRH (see Part VI and Attachment C), the home district
auditor, and the RRHR within 2 working days. \*

e.  When the above information is obtained by telephone response,
    follow-up to insure that receipt of the field test record is
    provided as soon as possible.

\* 2. Review the CDRH Field Correction Action Report (FCAR) and ensure
that all updates are added to the CDRH data base.

CAUTION: Unless responsibility has been clearly determined,
responsibility should be reported as \"Not Determined.\" CDRH generally
will not include in a legal action any test record for which the auditor
determines the responsible party is other than the assembler.

Forward assembler responses which allege manufacturer responsibility for
noncompliances to the home district auditor and HFZ‑300 for Center
follow-up. Include all documentation necessary to support this
conclusion. \*

C. [REPORTING BY THE HOME DISTRICT AUDITOR]{.underline}

Review the CDRH Field Correction Action Report (FCAR) and ensure that
all updates are added to the CDRH data base.

CAUTION: Unless responsibility has been clearly determined,
responsibility should be reported as \"Not Determined.\" CDRH generally
will not include in a legal action any test record for which the auditor
determines the responsible party is other than the assembler.

Forward assembler responses which allege manufacturer responsibility for
noncompliances to HFZ‑300 for Center follow-up. Include all
documentation necessary to support this conclusion.

D. [AUDITING ASSEMBLER CORRECTIVE ACTIONS]{.underline}

The accomplishing district auditor shall arrange the following testing:

\* 1. Within 10 working days following reported correction of all Class
A violations by the home district auditor. \*

2\. Within 30 days following reported correction for at least 10 percent
of the Class B violations.

Concentrate follow‑up field tests more heavily for:

1\. Assemblers who in the past have reported violative products to be
corrected when in fact they were not, and

2\. New assemblers with no established record of properly correcting
violative products.

[PART IV]{.underline}

No laboratory testing will be done under this program.

[PART V ‑ REGULATORY/ADMINISTRATIVE STRATEGY]{.underline}

A. [REGULATORY PHILOSOPHY AND STRATEGY]{.underline}

Diagnostic x-ray equipment is regulated under both Subchapter C ‑
Electronic Product Radiation Control (formerly the Radiation Control for
Health and Safety Act of 1968) and Subchapter A ‑ Drugs and Devices of
Chapter V of the Federal Food, Drug, and Cosmetic Act (FFDCA).
Subchapter C provides authority to require product recalls for
noncompliant or defective radiation‑emitting electronic products. In
addition, Subchapter A (as amended by the Safe Medical Devices Act)
provides authority to require product recalls for medical devices that
may cause a serious risk to health. (All diagnostic (medical) x-ray
products are medical devices.) When there is a choice,
regulatory/administrative action is preferred under Subchapter C, but
both portions of the FFDCA may be used in conjunction for maximum
effectiveness.

The primary enforcement approach for generic/design related violations
caused by the x-ray component manufacturer is mandatory recall (refer to
RPM Chapter 7, Attachment F for details). The CDRH is responsible for
initiating recalls by x-ray manufacturers and importers. For violations
which are attributable to the assembler, the field maintains
responsibility for enforcement.

Since x-ray assembly is more of a customized operation in which widely
varying random violations may occur, when a single system is discovered
noncompliant (as with our routine compliance testing program), a
product‑wide recall or civil penalty action is not generally applicable.
The primary assembler enforcement approach is issuance of a Notification
letter requiring correction of the cited violations on the unit tested,
followed by increased surveillance to establish a pattern of violation.
Once a pattern of violations is determined (see TABLE I Part II and CPG
7133.12) then the district should either issue a noncompliance
declaration with district ordered assembler recall (NC/DOAR) or pursue
civil penalties to dissuade further violations.

When a pattern of performance standard violations has been documented,
or the responses to Notification letters are unsatisfactory, or the firm
fails to file form FD 2579 after being previously advised in writing of
the consequences of continued failure to file, recommend appropriate
action against the assembler as described in CPG 7133.12.

In the absence of evidence to the contrary, for violative x-ray systems
found during field testing:

‑ the assembler is responsible if the unit was tested within one year of
installation

‑ the user is responsible if the unit was tested more than one year
after installation

Other relevant compliance policies, and mandatory recall,
detention/seizure and civil penalty procedures are contained in:

‑ CPG 7133.12 (Regulatory Actions Against Assemblers Who Install
Noncompliant Diagnostic X-ray Equipment.)

‑ CPG 7133.23 (Assessment of Civil Penalties Against Manufacturers and
Importers of Electronic Products.)

‑ CPG 7133.25 (Detention/Seizure ‑ Hazardous Diagnostic X-ray Systems,

July 1, 1983.)

‑ CPG 7133.27 (Corrective Actions ‑ Obligations of Factory‑Based
Manufacturers and Assemblers of Diagnostic X-ray Equipment under the
performance standard for Diagnostic X-ray Equipment.)

‑ CPG 7133.28 (Regulatory Actions Against Assemblers of X-ray Equipment
That Fail to File Reports of Assembly.)

‑ RPM Chapter 6 (Civil Penalties - Electronic Product Radiation Control)

‑ RPM Chapter 7, Attachment F (Recalls of Radiation‑Emitting Electronic
Products under Subchapter C Electronic Product Radiation Control)

B. [CASE GUIDANCE]{.underline}

Informal consultation with the Center at an early stage in the
development of a regulatory action is encouraged in order to facilitate
timely implementation of the action; contact the Chief, Diagnostic
Devices Branch, HFZ‑322, Phone: 301-594‑4591. All necessary samples and
other supporting documentation must be tabbed and their location
cross‑referenced in the recommendation in order to assist in a timely
review.

1\. [Assembler Violations]{.underline}

Recommend radiation control civil penalties (see CPG 7133.12 for
appropriateness) for:

‑ a pattern of violative field tests in accordance with Table I Part II
B.3. and CPG 7133.12.

‑ a pattern of failure to provide FDA with required assembler reports
meeting the criteria in CPG 7133.28.

‑ unsatisfactory responses to Notification letters or failure to correct
noncompliant products.

‑ deliberate and willful violations.

‑ violations occurring when NC/DOAR action is not appropriate or
adequate (see section D. below and Table I, Part II, B.3).

‑ the violation has resulted in serious injury or death.

Recommend medical device civil penalties as appropriate. Section 501(c)
charges can be used if the field test shows one or more assembler
related noncompliance for each unit.

2\. [Manufacturer Violations]{.underline}

Refer all Class A or Class B noncompliant test records attributable to
the x-ray system or component manufacturer to CDRH (HFZ‑322) for
evaluation and follow‑up action. The referral memo should include:

‑ A description of the noncompliance.

‑ Identity of the manufacturer(s) and model(s) involved.

‑ Reason for suspecting a manufacturer problem.

‑ Identity and date of any previous telephone contact with CDRH on the
problem.

‑ Whether the unit has been corrected.

If the unit has not been corrected, CDRH will request correction by the
manufacturer. If evaluation confirms a generic or design problem, CDRH
will declare noncompliance and require correction/recall in accordance
with RPM Chapter 7, Attachment F.

The home district will monitor approved corrective action programs
(recalls). It may be appropriate to recommend civil penalties for
failure to correct noncompliant products or for continuing or willful
violations.

3\. Detention/Seizure

Recommend detention/seizure for serious radiation hazards if the
responsible firm (manufacturer or assembler) refuses to correct or is
unable (e.g. out of business) to correct the hazard. Serious radiation
hazards include the following or similar situations (see CPG 7133.25):

‑ Non-termination of the x-ray timer,

‑ Excessive entrance exposure rate on fluoroscopic units.

Direct reference authority is provided for seizure actions when an
administrative detention action has previously been approved.

C. [ISSUANCE OF NOTIFICATION LETTERS FOR NONCOMPLIANCE WITH THE STANDARD
WHERE THE ASSEMBLER IS SUSPECTED TO BE RESPONSIBLE]{.underline}.

\* NOTE: All untitled letters should be reviewed by the accomplishing
district auditor prior to issuance. Class A violations are issued as
Warning Letters by the home district and should be reviewed by the home
district auditor. \*

1\. Assembly of Noncompliant Diagnostic X-ray Systems

a\. Issue a Notification letter (see Attachment K) to the responsible
assembler for Class A and Class B field test results obtained within one
year of installation. Notification letters shall issue:

‑ Addressed to the most responsible individual at the local assembler
firm.

‑ Warning of civil penalties in accordance with Chapter 6 of the
Regulatory Procedures Manual.

‑ Within 45 days of the field test (60 days for state tests).

‑ Within 2 days after receipt of results showing Class A violations.

‑ Within 10 working days after receipt of results showing Class B
violations.

‑ Requesting assembler response within 15 working days after receipt for
all Class A or within 30 working days for all Class B violations.

‑ Requesting a copy of the assembler service report (to help determine
the cause of the violation and to assure correction at no cost to the
user).

‑ With copies of the Notification letter in every case sent to:

a\) the user

b\) the x-ray or medical systems headquarters official responsible for
the local assembler firm

c\) the x-ray control manufacturer\'s corporate headquarters officials
identified in Attachment G. If the violative product is a beam limiting
device (BLD), the BLD manufacturer\'s corporate headquarters official
identified in Attachment G will receive a copy if different from the
x-ray control manufacturer\'s firm.

\* d) the home district auditor (auditor will review all warning letters
prior to being issued) \*

\* e) the accomplishing district auditor (auditor will review all
untitled letters prior to being issued) \*

f\) CDRH, HFZ-300.

g\) The State Radiological Health Agency

b\. Evaluate the assembler\'s response and route a copy to the home
district x-ray auditor for confirmation of responsibility, assessment of
qualification for civil penalties recommendation, and completion of CDRH
Field Correction Status Report.

c\. Respond to refutations or exemption requests when the assembler
exercises his rights under 21 CFR 1003.30. Obtain technical assistance
from the auditor or CDRH personnel listed in Attachment B, if necessary.

d\. Disapprove unsatisfactory corrective actions proposed or performed
by assemblers.

e\. If the assembler fails to provide a satisfactory or timely response,
issue an assignment for follow‑up field testing. If the violation is not
corrected, consider regulatory action.

NOTE: When an assembler disagrees with Agency action, he may request a
hearing under 21 CFR 16. If such a request is received by the district,
contact HFZ‑300 so that arrangements may be made to designate a hearing
officer in accordance with 21 CFR 5.30(c).

2\. [Failure to Submit, Late Submission of, or Errors in the Submission
of FDA 2579, Report of Assembly of Diagnostic X-ray Systems]{.underline}

Issue a Notification letter to the most responsible person at the local
assembler\'s office (see Attachments H through J).

NOTE: Submission of a 2579 more than 30 days after assembly is
considered late.

D. [ISSUANCE OF WARNING LETTER, NONCOMPLIANCE DECLARATION AND DISTRICT
ORDERED ASSEMBLER RECALL (NC/DOAR WARNING LETTER) FOR ASSEMBLER
RESPONSIBLE NONCOMPLIANCES WITH THE STANDARD]{.underline}. (NOTE: All
NC/DOAR letters should be reviewed by the home district auditor prior to
issuance.)

1\. [Assembly of Noncompliant Diagnostic X-ray Systems]{.underline}

a\. Issue a NC/DOAR warning letter (see Attachment P) to the responsible
assembler in accordance with CPG 7133.12 and Table I of Part II. Address
the letter to the most responsible individual at the local assembler
firm. Copies of the NC/DOAR letter should be sent to the home district
auditor, installation district auditor, the RRHR and HFZ‑300.

b\. Evaluate the assembler response using the guidance of Attachment Q.
Full use of the home district auditor and contacts with the Diagnostic
Devices Branch are advised to assist in the technical aspects of
determining acceptable responses.

2\. [Monitoring Assembler Corrective Action Plans]{.underline}

When Notification letters are issued as follow‑up to a violative routine
field test, the assembler is not required to submit a corrective action
plan (CAP) for the correction of the one individual unit. To require
submission of a CAP for individual violations would prolong indefinitely
the correction of violative products.

Under the NC/DOAR action, FDA Districts will issue noncompliance
declarations to specific assemblers, covering all assemblies of fully
certified diagnostic x-ray systems assembled over a prescribed time
period. Thus, it is essential that a CAP be submitted to, and monitored
by, the assemblers home district. Monitoring begins when it is
determined that the assembler has elected to submit a CAP in lieu of a
refutation or exemption request. Review of the technical aspects of the
CAP should be the responsibility of the home district x-ray auditor. If
assistance is needed, the auditor should contact the Diagnostic Devices
Branch (HFZ‑322) at (301)-594-4591. Guidance for evaluating assembler
responses can be found in Attachment Q.

Assembler CAPs are to be handled as recalls. The procedures for handling
recalls are detailed in the Regulatory Procedures Manual (RPM), Chapter
7. Attachment F of the RPM provides specific guidance for x-ray
assemblers.

The home district should incorporate the following steps as part of the
CAP monitoring:

a\. Upon receipt of a CAP, prepare the Recall Alert described in the
RPM.

b\. Schedule an establishment inspection of the assembler to obtain
additional details of the CAP. During this inspection, the investigator
should obtain the information necessary for submitting a Recall
Recommendation.

Note: The district should allow the assembler up to 30 days to formulate
a complete CAP and to submit it in writing. Delay submitting the Recall
Recommendation until this information is received. Although the
Regulations do not require FDA to provide the assembler with this 30‑day
grace period, additional time should be permitted to prepare a complete
CAP since the CAP submission by an assembler has not normally been
required.

c\. If there will be a delay in obtaining complete details of a CAP,
advise the assembler that he must provide interim purchaser notification
pursuant to 21 CFR 1003.21. A model letter to purchasers is included as
Attachment R.

d\. Once a complete CAP is received, the district x-ray auditor should
review the CAP, and if acceptable, prepare a CAP approval letter
(Attachment S) for the signature of the District Director.

e\. Copies of the CAP approval letter should be sent to the Diagnostic
Devices Branch (HFZ‑322).

f\. The Diagnostic Devices Branch, DOE I, OC, CDRH will assign the
recall number, recall strategy, and recall classification as directed in
the RPM.

g\. Upon receipt of the recall number, strategy, and classification by
CDRH, the district will prepare the recall notification.

h\. The district will also, upon receipt of the recall information from
CDRH, prepare a notification letter to the recalling firm setting forth
the Agency\'s position regarding the recall. Include instructions for
submitting monthly progress reports, if not included in the CAP approval
letter.

i\. Once the assembler reports completion of the CAP, the district can
begin to schedule audit checks at purchaser locations as assigned by
CDRH in the Recall Strategy Statement. Audit checks should be performed
within six months of the date of correction by the assembler and should
consist of a complete field test of the system utilizing the appropriate
field test method. The focus of the audit checks should be on the
noncompliances cited in the original Warning Letter. Under some
circumstances when the recall takes longer than 6 months, an audit check
can begin before the completion of the CAP on all locations (see RPM
Chapter 7 Attachment F). Generally audit checks are performed on 10% of
the product under recall.

j\. The recall should be declared effective if all audit checks
demonstrate full compliance with the elements of the Performance
Standard cited in the original Warning Letter. Prepare a Recall
Termination Recommendation at that time.

Note: Since the number of audit checks will normally be small, a
decision regarding the effectiveness will not be made if only one of the
audited units fails to comply. A second series of audit checks should be
conducted at purchaser locations, using the sampling criteria of
ANSI/ASQ Z1.4. An identical number of units should be audited in both
the first series and second series of audit checks. If the second series
of the audit checks reveals no noncompliances, then the recall is
effective. The recall shall be considered ineffective if during the
first series of audit checks, more than one unit fails to comply with
the Performance Standard as cited in the original Warning Letter, or, if
during the second series of audit checks, one or more units fail to
comply.

k\. Whenever an audit check detects an item of noncompliance (covered by
the CAP) that has not been corrected, issue a Notification letter to the
assembler. If two or more such noncompliant systems are encountered
which are assembler related (not caused by user abuse or failed
component), prepare a recommendation for civil penalty.

Note: CDRH will not consider for inclusion in a civil penalty case any
noncompliance for which the responsible party is identified as other
than the assembler. The Field Corrective Action Report must identify the
assembler as the responsible party.

3\. [Preparing the Recall Alert]{.underline}

In preparing the 24‑hour recall alert (Attachment A of RPM Chapter 7),
the following standard responses should be used:

a\. Product ‑ All assemblies of certified diagnostic x-ray systems
performed between \_\_\_\_\_\_and \_\_\_\_\_\_.

b\. Code ‑ All makes and models, including
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ and
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_.

c\. Recalling Firm ‑ List the names and address of the assembler.

d\. Reason for Recall ‑ Field test data collected by the FDA establishes
that the recalling firm was routinely assembling certified diagnostic
x-ray systems which failed to comply with the Performance Standard. The
district issued a noncompliance declaration letter dated \_\_\_\_\_\_\_.
The assembler responded with a CAP dated \_\_\_\_\_\_\_.

e\. District Follow-Up - Include plans for any follow-up establishment
inspection and whether or nor the CAP appears complete.

f\. Date district learned of recall - Date of CAP letter from the
assembler.

g\. Recall initiation date - the date the CAP is received in the home
district.

4\. [Preparing the Recall Recommendation]{.underline}

a\. Product ‑ Certified diagnostic x-ray systems assembled by
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ between
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ and \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_.
The products are used on a daily basis for diagnostic radiology. All
units are involved in this corrective action plan.

b\. Code ‑ Various

c\. Recalled By & How ‑ The assembler, \_\_\_\_\_\_\_\_\_\_\_, will test
all systems for compliance with the Performance Standard, making the
necessary corrections to bring each system into compliance.

d\. Manufacturer ‑ Products are assembled by the recalling firm using
certified diagnostic x-ray components from a variety of manufacturers.

e\. Date of recall ‑ The date of the CAP. Since the CAP approval letter
has not been issued, this is the date of the assembler response to the
noncompliance declaration.

f\. Reason ‑ As described in Attachment A.

g\. Distribution ‑ Self explanatory.

h\. Quantity ‑ The number of certified x-ray systems covered by the CAP.

i\. Current Status ‑ Recall not started; Cap must be approved.

E. [ISSUANCE OF INFORMATION LETTERS FOR USER CAUSED VIOLATIONS AND
REFERRAL TO STATE AUTHORITIES]{.underline}

1\. Issue information letters to users when field test results are
obtained more than one year after installation and/or violations cannot
be determined to be the fault of the manufacturer or assembler (see
Attachment M). Send copies to the appropriate state radiation control
authorities, the assembler, the component manufacturer, the RRHR for
State coordination, the home district auditor, the installation district
auditor, and

HFZ‑300.

2\. If the user fails to respond, notify state authorities and the RRHR
and request their assistance in obtaining correction. Also request state
assistance to prevent use of a Class A violative product until it is
corrected. If the state is unable or unwilling to gain compliance:

‑ For non-termination of the x-ray timer only, consider
detention/seizure in accordance with CPG 7133.25.

‑ For all other Class A violations, contact HFZ-300.

‑ For Class B violations, do not pursue the matter further.

3\. Advise the home district auditor of all final actions or failures to
obtain correction so that the Field Corrective Action Report (FCAR) may
be completed.

F. [FEDERAL/STATE RELATIONS]{.underline}

The RRHR will coordinate and supervise voluntary working agreements,
agency contracts and/or Partnership Agreements (PA) with states
performing diagnostic x-ray field testing.

[PART VI ‑ REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS]{.underline}

A. REFERENCES

1\. Title 21 Code of Federal Regulations, Subchapter J. [Radiological
Health]{.underline}.

2\. Subchapter C Electronic Product Radiation Control of Chapter V of
the Federal Food, Drug, and Cosmetic Act.

3\. FDA Regulatory Procedures Manual, Chapter 7, Attachment F and
Chapter 6.

4\. BRH \"Routine Compliance Testing for Diagnostic X-ray Systems or
Components of Diagnostic X-ray Systems to which 21 CFR Subchapter J is
Applicable\", Revised December 1980, DHEW Publication (FDA) 81‑8161.

5\. Office of Radiological Health, Division of Compliance, [Assemblers
Guide to Diagnostic X-ray Equipment]{.underline}. (Rockville, Maryland).

6\. United States Code, Title 21, [Federal Food, Drug, and Cosmetic Act,
As Amended]{.underline}

7\. Compliance Policy Guide 7133.12, Regulatory Actions Against
Assemblers Who Install Noncompliant diagnostic x-ray equipment.

8\. \"Calculation Programs for Routine Compliance Testing of Diagnostic
X-ray Systems\".

9\. Compliance Policy Guide 7133.23, Assessment of Civil Penalties
Against Manufacturers and Importers of Electronic Products.

10\. Compliance Policy Guide 7133.25, Hazardous Diagnostic X-ray
Systems.

11. Investigations Operations Manual (IOM).

12. Compliance Policy Guide 7133.27, Obligations of Factory-based
    Manufacturers and Assemblers of Diagnostic X-Ray Equipment Under the
    Performance Standard for Diagnostic X-Ray Equipment.

13. Compliance Policy Guide 7133.28, Regulatory Actions Against
    Assemblers of X-Ray Equipment that Fail to File Reports of Assembly.

B. [ATTACHMENTS]{.underline}

1\. Attachment A ‑ List of CDRH, MEB, Personnel to Contact on
Procurement, Maintenance and Repair of Instrumentation.

2\. Attachment B ‑ List of CDRH Personnel to Contact on Test Procedures,
Use of Instrumentation, and Data Entry Problems.

3\. Attachment C ‑ General Communications List.

4\. Attachment D ‑ Classification of Items of Noncompliance and Defects.

5\. Attachment E ‑ Sample Report of Assembly of a Diagnostic X-ray
System (FDA‑2579).

6\. Attachment F ‑ Form FD‑2766 Claim for Damages to Electronic
Products.

7\. Attachment G ‑ Contacts for Manufacturers of Diagnostic X-ray
Systems Controls.

8\. Attachment H ‑ Notification letter to the Assembler (Incomplete or
incorrect FDA‑2579 Report of Assembly).

9\. Attachment I ‑ Notification letter to Assembler ‑ Standards
Violation Found During Review of FDA‑2579\'s or Records Review at the
Assembler.

10\. Attachment J ‑ Notification letter to the Assembler (Failure to
File FDA‑2579 Report of Assembly).

11\. Attachment K ‑ Notification letter to the Assembler. (Notification
of Defect or Noncompliance on FD‑2786 Field Test).

12\. Attachment L ‑ Field Correction Status Report

13\. Attachment M ‑ Notification Letter to the User (Notification of
Noncompliance Attributable to User Actions or Inaction).

14\. Attachment N ‑ Responsibility for Defects or Noncompliances.

15\. Attachment O ‑ Listing of Qualified X-ray Auditors

16\. Attachment P ‑ Sample Warning letter-Noncompliance Declaration With
District Ordered Assembler Recall Letter to X-ray Assemblers.

17\. Attachment Q ‑ Guidance for Evaluating an Assembler Response to a
Noncompliance Declaration With District Ordered Assembler Recall Letter.

18\. Attachment R ‑ Sample User Notification Letter for Assembler
Noncompliances and CAPs.

19\. Attachment S ‑ Sample CAP Approval Letter to X-ray Assemblers.

C. [PROGRAM CONTACTS]{.underline}

1\. [CDRH Contact]{.underline} ‑ Questions concerning this compliance
program should be directed to the Field Programs Branch, Division of
Program Operations, Office of Compliance, CDRH, telephone number (301)
594‑4695. Secondary contact may be made with individuals listed on
Attachment C.

2\. [ORA Contact]{.underline} ‑ The ORA Headquarters contact for this
compliance program is ORO/DEIO (HFC-130), Cdr. James M. Simpson, USPHS,
telephone number (301) 827-1124.

[PART VII ‑ CENTER RESPONSIBILITIES]{.underline}

A. The CDRH shall:

1\. Monitor nationwide noncompliance trends for different types of x-ray
systems and for various plant based x-ray manufacturers.

2\. Declare noncompliance and require product recall by manufacturers
where nationwide field test data indicates a noncompliance rate well
above the national average, or where design related generic violations
are identified.

3\. Provide calibrated test equipment for use by FDA and state
inspectors.

4\. Develop computer listings of all certified models of diagnostic
x-ray components and systems (Manufacturers Model List) and provide
these to each Region and District.

5\. Routinely provide listings of problem assemblers for concentrated
field testing and enforcement action.

6\. Provide periodic status reports on assembler noncompliance trends,
and special reports on request by the District.

7\. Maintain/develop computer software for direct access to CDRH
computer data by Auditors and District DPU\'s.

8\. Date‑stamp assembler reports (FDA‑2579) as received, enter the data
into the data base, and mail forms to the appropriate accomplishing
district investigations branch weekly for review for testing selections.

9\. Recommend specific sites for special tests when necessary. Survey
forms and special test procedures will be provided by the Office of
Compliance. Portable test equipment will be supplied if needed by the
Office of Science and Technology.

10\. Provide the field with information concerning system and component
manufacturers corrective action plans. This information will include
procedures for monitoring these plans. Advise the field of legal
opinions, including those compliance cases, and advisory opinions which
impact on their responsibilities in dealing with assemblers.

11\. Provide the field with a listing of unresolved noncompliances on a
routine basis (Field Correction Status Report) and provide a procedure
for each district to monitor their status of unresolved noncompliances.

12\. Provide originals of all FD 2579 reports of assembly to the
installation district.

13\. Monitor and evaluate all test records, assignments, and
correspondence relating to this program to identify trends or problems
with the program.

14\. Resolve specific program problems with the district office or ORA
as soon as they are identified.

B. Program Evaluation ‑ Within 3 months after receipt of all
documentation for the fiscal year, an informal evaluation will be
conducted to review the results of this program and any needed
improvements to increase program effectiveness. No formal written
evaluation report will be prepared unless requested by the Director,
Office of Compliance.