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August 12, 2003

**National Electrical Manufacturers Association**

1300 North 17th Street, Suite 1847, Rosslyn, VA 22209

www.nema.org tel: 703-841-3200 fax: 703-841-5900

Dockets Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

Re: Docket No. 03N--0094

Annual Guidance Agenda

Federal Register Notice/ Vol. 68, No. 65 / Friday, April 4, 2003

To Whom It May Concern:

On behalf of the Diagnostic Imaging and Therapy Systems Division of
NEMA, we are pleased to submit comments in response to the subject
notice. NEMA, the National Electrical Manufacturers Association, is the
nation's largest trade association representing the electro-industry.
NEMA's Diagnostic Imaging and Therapy Systems Division represents the
majority of the nation's manufacturers of X-ray imaging, computed
tomography, diagnostic ultrasound, radiation therapy, magnetic resonance
imaging, and nuclear imaging equipment. In addition, the division
represents manufacturers of picture archiving and communications
systems.

**NEMA supports and encourages the issuance of Draft Guidance on the
Reports of Corrections and Removals Regulation as soon as possible.**

NEMA is pleased to see the **Draft Guidance on the Reports of
Corrections and Removals Regulation** on the FDA's Annual Guidance
Agenda list.

Section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360i(f)) directs FDA to issue regulations to require device
manufacturers and importers to report promptly to FDA, any correction or
removal of a device undertaken by such manufacturers and importers, if
the correction or removal was undertaken to reduce a risk to health
posed by the device or to remedy a violation of the act caused by the
device which may present a risk to health. Under 21 CFR 806.10 and
806.20(a), FDA requires that each device manufacturer and importer shall
submit a written report to FDA of any action initiated to correct or
remove a device to reduce a risk to health posed by the device or to
remedy a violation of the act caused by the device which may present a
risk to health within 10-working days of initiating such correction or
removal. In addition, each manufacturer and importer of a device who
initiates a correction or removal of a device that is not required to be
reported to FDA, shall keep a record of such correction or removal.

NEMA member companies are Respondents to this information collection,
hence are impacted by relevant guidance.

####### Consistent interpretation of regulation is important

The information collected in the reports of corrections and removals is
used by FDA for the important purpose of identifying marketed devices
that have serious problems and to ensure that dangerous and defective
devices are removed from the market, and of assuring that FDA has
current and complete information regarding these corrections and
removals and whether recall action is adequate. In order to achieve
consistency in FDA's database it is important that field inspectors
interpret the regulation uniformly.

**Provide definitions and examples to help uniform interpretation
because the terms in the regulation are not defined**

NEMA offers the definitions and examples in Attachment A to this letter
for inclusion in the Draft Guidance to achieve uniform interpretation by
FDA inspectors and manufacturers alike.

**Examples and definitions must be incorporated in field inspection
manuals to achieve the desired result.**

In order that the geographically diverse inspection staff implement the
regulation uniformly the relevant and practically worded guidance,
illustrated with examples, should be incorporated in the field manuals
as soon as possible.

Unwarranted reporting causes unnecessary costs and limits access to
diagnostic devices. This much-needed Guidance, when incorporated in
field manuals, will minimize cost and prevent unwarranted limitation of
access to diagnostic imaging devices.

NEMA is pleased to submit these comments and may provide additional
suggested examples for use in the draft guidance. We look forward to
working with the agency.

> ![](media/image2.bmp)Sincerely yours,

Robert G. Britain

![](media/image3.wmf) Vice President - Medical Products

Stephen A. Vastagh

Industry Manager -- Medical Products

cc: Casper Uldriks, CDRH

[mailto:CEU@CDRH.FDA.GOV](mailto:CEU@CDRH.FDA.GOV)

ATTACHMENT A -- Definitions and Examples

GENERAL CORRECTIONS AND REMOVALS GUIDANCE

(7382.845 Attachment G)

This document provides general guidance regarding the reporting of
corrections or removals of a medical device required by the Reports of
Corrections and Removals (CAR) Regulation, 21 CFR Part 806.

A. [CORRECTION]{.underline}

> The CAR regulation defines 'correction' to mean the repair,
> modification, adjustment, relabeling, destruction, or inspection
> (including patient monitoring) of a device without its physical
> removal from its point of use to some other location.
>
> When actions are taken to improve the performance or quality of a
> device (but that do not reduce a serious risk to health posed by the
> device) or are carried out in accordance with the definition of
> routine servicing, the activity is not considered a reportable
> correction. For example, software upgrades to decrease acquisition
> time, or to fix software \"bugs\" that do not pose a significant risk
> to health and safety would not be reportable.

B. [REMOVAL]{.underline}

> The CAR regulation defines 'removal' to mean the physical removal of a
> device from its point of use to some other location for repair,
> modification, adjustment, relabeling, destruction, or inspection.
>
> When actions are taken to improve the performance or quality of a
> device (but that do not reduce a serious risk to health posed by the
> device) or are carried out in accordance with the definition of
> routine servicing, the activity is not considered a reportable
> removal.

C. [ROUTINE SERVICING]{.underline}

> The CAR regulation defines 'routine servicing' to mean any regularly
> scheduled maintenance of a device, including the replacement of parts
> at the end of their normal life expectancy, e.g., calibration,
> replacement of batteries, and responses to normal wear and tear.
> Repairs of an unexpected nature, replacement of parts earlier than
> their normal life expectancy, or identical repairs or replacements of
> multiple units of a device are not routine servicing.
>
> For some devices, particularly electro-mechanical systems, activities
> such as maintenance, calibration, adjustment, and inspection are
> elements of normal use. These devices are often provided with
> documentation such as installation, operator, and service manuals to
> ensure continued safety and performance. Servicing performed in
> accordance with procedures given in these manuals is planned and
> expected and is considered routine service. Service that requires
> specially designed parts from the manufacturer is not regarded as
> routine service.
>
> The following are examples of servicing that would not require
> submission of a CAR report:
>
> Repair unique to a single system due to random failure, e.g., diode
> failure on printed circuit board and a service engineer replaces the
> board.
>
> Correction to multiple systems due to misuse or abuse, e.g., user
> fails to arrange for preventive maintenance that includes annual
> inspection of support cables to ensure replacement before failure and
> manufacturer sends periodic reminder letter.
>
> Modification to improve safety or reliability of properly operating
> system, e.g., service engineer improves mean-time-between-failure on
> mobile x-ray unit used in emergency room by replacing failed x-ray
> tube with a new model having a longer tube life.
>
> Improve image quality on properly operating system, e.g., manufacturer
> provides replacement solid state detector elements with scintillator
> having a longer life thus reducing the chance of image artifacts and
> potential misdiagnosis.
>
> Repair a safety mechanism on a system that failed safe, e.g.,
> replacement of the safety catch mechanism that prevented injury but
> was damaged when a support cable broke.
>
> Repairs to a system due to customer neglect, e.g., service engineer
> replaces protective covers that had been damaged or discarded by user.
>
> Restore a system to use that failed during an interventional
> procedure, e.g., replacement of a failed x-ray tube on a vascular
> imaging system.

# D. RISK TO HEALTH

> The CAR regulation describes 'risk to health' as those situations that
> could result in adverse health consequences for which the remedial
> action meets the definition of a Class I or Class II recall. The
> regulation does not specify more precisely what constitutes an
> 'adverse health consequence'. The term 'serious, adverse health
> consequences' is defined elsewhere in 21 CFR section 810.2(i) as any
> significant adverse experience, including those that may be either
> life-threatening or involve permanent or long-term injuries, but
> excluding injuries that are nonlife-threatening and that are temporary
> and reasonably reversible. Injuries that are nonlife-threatening and
> that are temporary and reasonably reversible are considered serious
> when medical intervention is required according to the definition of
> serious injury in the MDR regulation. Minor injuries treatable with
> only first aid and not requiring additional medical intervention do
> not fall within the scope of adverse health consequences, are not
> reportable for the MDR regulation, and would also not be considered a
> 'risk to health' under the CAR regulation.
>
> The following is a list of hazards and examples of when the actions
> taken may or may not be reportable. The need for a CAR report should
> be based on the type of potential injury.
>
> Mechanical hazard -

-   A CAR report would be required for action taken to prevent
    concussion, contusion, or broken bones that require medical
    intervention.

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-   A CAR report would not be required for action taken to prevent
    scratch, pinch, bruise, or fall treatable with only first aid.

Electrical hazard -

-   A CAR report would be required for action taken to prevent shock or
    electrical burn resulting in serious injury.

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-   A CAR report would not be required for action taken to prevent shock

> within established safe current limits (e.g. limits described in IEC
> 60601-1, Medical electrical equipment Part 1: General requirements for
> safety and essential performance), simple startle reaction without
> serious injury, or skin reddening treatable with only first aid.
>
> Chemical hazard -

-   A CAR report would be required for action taken to prevent fire in
    an area of flammable materials.

-   A CAR report would not be required for action taken to prevent
    combustion within a flame resistant enclosure with only a risk of
    minor smoke irritation.

> Radiation hazard -

-   A CAR report would be required for action taken to prevent loss of
    patient data resulting in re-exposure of multiple patients to a CT
    or

> X-Ray examination due to the additional potential ionizing radiation
> hazard.

-   A CAR report would not be required for action taken to reduce the
    likelihood of re-exposure of a patient to a MR or ultrasound
    examination where there is no ionizing radiation.

Misdiagnosis hazard -

-   A CAR report would be required for action taken to prevent
    misdiagnosis if it led to mistreatment resulting in serious injury.
    For example, correcting errors in the left-right annotation for head
    images would be reportable since the anatomical symmetry of the head
    might lead to incorrect treatment.

-   A CAR report would not be required for action taken to correct image
    artifacts or image annotation issues where the medical professional
    has complementary patient information or data that reduces the
    likelihood of misdiagnosis. For example, errors in the
    anterior/posterior annotation for head images, would not likely lead
    to mistreatment because of obvious anatomical markers, such as the
    eyes.

General -

-   A CAR report would be required for action taken to address an issue
    not already addressed in the above categories where there is a
    potential for serious adverse health consequences based on the
    factors such as detectability by the user, severity, and frequency.

-   A CAR report would not be required for action taken to address an
    issue not already addressed in the above categories where there is
    low potential for serious adverse health consequences based on the
    factors such as detectability by the user, severity, and frequency.

> Customer communications regarding potential hazards --

-   A CAR report would be required for communications alerting medical
    device users about potential unexpected malfunctions that are likely
    to result in serious injury.

-   A CAR report would not be required for communications to remind
    customers about a concern with the usage of the medical device that
    was previously included in labeling provided with the device.
    Another example of a non-reportable communication is one such as the
    Year-2000 alerts provided by manufacturers to customers since the
    risks were not likely to result in serious injury.

-   A CAR report would not be required for communications to alert
    customers on the risks associated with misuse of a device (that led
    to actual patient serious injury) that is contrary to the labeling
    currently provided with the device.

E. [RECORDKEEPING]{.underline}

> The CAR regulation requires manufacturers and importers who initiate a
> non-reportable correction or removal of a device to keep a record of
> such correction or removal. Each device manufacturer or importer
> required to maintain these records shall upon request of an officer or
> employee designated by FDA permit the officer or employee at all
> reasonable times to have access to the records.
>
> Manufacturers may have multiple production facilities and may manage
> the CAR reporting and record keeping elsewhere. Importers for foreign
> manufacturers may maintain CAR records domestically. It is not
> required that CAR records be maintained at the facility where the
> medical device is produced. However, the records must be reasonably
> accessible to inspection either at the record keeping location or,
> alternatively, copies may be transmitted on request for inspection at
> the production facility if provided in a reasonably timely manner
> considering the relative locations involved.
>
> Records of routine servicing are not considered CAR records.
>
> END OF ATTACHMENT