**[ATTACHMENT E]{.underline}**

### SUMMARY OF MDR REPORTING REQUIREMENTS

##### Individual Adverse Event Reports - 803.50

[General Requirements:]{.underline}

-   Manufacturers must submit death, serious injury, and malfunction
    reports within 30 days after they become aware of a reportable
    event.

-   The information can come from any source.

-   Devices that \"may have caused or contributed\" to a death or
    serious injury; or a malfunction that would be likely to cause or
    contribute to a death or serious injury must be reported.

[Reasonably known:]{.underline}

-   Firms must provide all information that is reasonably known to them.
    FDA considers the following to meet this standard, i.e., any
    information:

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-   that can be obtained by contacting a user facility, distributor,
    and/or other initial reporter,

-   in the manufacturer\'s possession,

-   that can be obtained by analysis, testing, or other evaluation of
    the device.

[Information required to be reported:]{.underline}

-   The form FDA 3500A is the primary reporting form for death, serious
    injury and malfunction events. With the exception of drug or
    biologic related items, all the fields must be completed or have an
    entry (NA, NI, OR UNK) indicating why the information could not be
    obtained.

[Missing Information:]{.underline}

-   Manufacturers are responsible for obtaining and providing FDA with
    any information that is missing from reports that are received from
    user facilities, distributors, and other initial reporters.

-   If a firm cannot provide complete information, it must provide a
    statement explaining why such information was incomplete and the
    steps taken to obtain the information.

-   Any required information not available at the time of the report,
    obtained at a later date, must be forwarded to FDA in a supplemental
    report within 1 month of receipt.

[Investigation:]{.underline}

-   Manufacturers are responsible for investigating and evaluating the
    cause of each event.

-   These investigations must follow the requirements in 820.198 and
    provide the information required on form FDA 3500A, Block H.6, H.7,
    and H.9.

[Five-Day Reports - 803.53:]{.underline}

-   Manufacturers must submit a five-day report on form FDA 3500A within
    five days under the following two conditions:

> a\. They become aware that an MDR reportable event, from any source,
> requires remedial action to prevent an unreasonable risk of
> substantial harm to the public health.
>
> OR
>
> b\. They receive an FDA written request for the submission of five-day
> reports.

[Baseline Reports - 803.55:]{.underline}

-   Manufacturers are required to submit a baseline report on FDA 3417
    form when the device model is first reported under 803.50.

-   Baseline Reports must be updated annually (if information changes)
    on the firm\'s scheduled registration date, as required by Part
    807.21.

> NOTE: The following MDR requirements have been stayed or revoked:
>
> 1\. Certification, 21 CFR 803.57,

2.  U.S. Designated Agent requirements, 21 CFR 803.58, 807.3, 807.20 and
    807.40, and,

3.  Baseline Reports, only sections 21 CFR 803.55(b) (9) and (10), which
    correlate to items 15 and 16 on the Baseline Report form, FDA 3417.

[Supplemental Reports - 803.56:]{.underline}

-   Manufacturers are required to submit, within one month after receipt
    any required information regarding deaths, serious injuries, and
    malfunctions that was not available to them when the initial report
    was submitted.

###### GENERAL MDR GUIDANCE

This document provides general guidance regarding the reporting of
adverse events required by the Medical Device Reporting (MDR)
Regulation.

A. [PER SE RULE]{.underline}

This requirement no longer exists. Therefore, the submission of an event
by a health care professional does not require the manufacturer to
report the event based solely on the statements of a health care
professional. The event must meet the reporting criteria in MDR to
qualify as a reportable event.

B. [REPORTING TIME FRAMES]{.underline}

Firms now have up to 30 CALENDAR days after they become aware of a
device related death, serious injury or malfunction before they are
required to submit a report to FDA.

C. [FIVE-DAY REPORTS]{.underline}

Five-day reports are required in two circumstances. First, they are
required if a manufacturer becomes aware that a reportable event, from
any source of information, necessitates remedial action to prevent an
unreasonable risk of substantial harm to the public health. Second,
five-day reports are required when a manufacturer becomes aware of an
MDR reportable event for which FDA has requested a five-day report.

D. [NON-REPORTABLE EVENTS]{.underline}

> Firms must submit MDR reports when the reported information
> [reasonably suggests]{.underline} an association between one of its
> devices and a reportable death, serious injury or malfunction. Under
> some circumstances, an adverse event may appear to trigger the
> requirement of submission of an MDR, but because information reveals
> the device did not cause or contribute to the death or serious injury,
> no MDR is required. Thus as described below, a manufacturer will have
> to investigate the event in order to know if it should be reported.

A firm is required to submit an MDR report when it becomes aware of
information reasonably suggesting that an event meets the criteria for
reporting a Death, Serious Injury, or Malfunction. For example, a
hospital informs a manufacturer that its device has failed and, as a
result, a patient died. At this point, the firm has become aware of
information that reasonably suggests they are in receipt of a reportable
MDR event.

> Next, the firm must investigate the report to determine its cause.
> Both the QS Regulation and MDR require investigation of complaints.
> During its investigation a firm may become aware of information that
> changes the initial report\'s conclusions. For example, the firm may
> find that its device was not involved in the death and could not have
> caused or contributed to the death. In these instances the firm would
> document the information that changes the association between its
> device and the death. No report would be required if the death or
> other facts turn out to be incorrect. But, if the firm becomes aware
> of the identity of the device/firm that was associated with the death,
> the firm is responsible for forwarding the information to the FDA.

However, if the firm\'s investigation does not change the alleged
association between the device and the death, the event must be
submitted as an MDR report. In addition, if the firm\'s investigation
produces information that would cause a person who is qualified to make
a medical judgment to reach a reasonable conclusion that the device did
not cause or contribute to a reportable MDR event - no report is
required. Translation - if a firm decides NOT to report an apparent
device-related death, serious injury or malfunction - this decision must
be made by a person that the regulation recognizes as qualified to make
a medical judgment, i.e., a physician, nurse, risk manager, or
biomedical engineer. Using the example from above, if the firm\'s
investigation yields an autopsy finding that the patient died from
cancer -- not the device - the firm could decide NOT to report as long
as the decision is consistent with the regulation:

1.  There is documented information that changes the association between
    the death and the device,

#### The decision is made by a person who is qualified to make a medical judgement, and 

2.  The conclusion reached by the person in item two is reasonable.

PLEASE NOTE THE FOLLOWING:

-   Firms ARE NOT required to have every MDR report reviewed by a person
    qualified to make a medical judgement and/or a person with a medical
    degree or training. Individuals who are not qualified to make a
    medical judgement can review MDR reports and make decisions on the
    basis of facts but they cannot make decisions NOT to report MDR
    events that require medical judgement.

-   In lieu of in-house or on-site qualified medical personnel or
    individuals qualified to make a medical judgement the firm may use
    consultants.

-   When reviewing a non-reportable event validate and document the
    credentials of the individual making these decisions as well as the
    decision not to report the event.

E. [INVESTIGATION]{.underline}

Firms are required to investigate EVERY device related death, serious
injury and malfunction in accordance with QS/GMP regulation, 820.198.
Failure to comply with this provision is a violation of BOTH the QS/GMP
regulation and MDR. Manufacturers are also required to VERIFY
information on each form FDA 3500A as well as make a good faith effort
to obtain information that is missing/not provided by the reporter. If
the firm cannot obtain the missing information, the MDR complaint files
shall contain an explanation of why the information could not be
obtained as well as documentation of the firm\'s efforts to obtain the
missing information.

F. [REASONABLY KNOWN INFORMATION]{.underline}

FDA considers information that can be obtained by contacting the
reporter to be in the possession of a firm, and considers information
that can be obtained by analysis, testing, or other evaluation of a
device to be information that a firm is expected to REASONABLY know,
obtain and report.

G. [REASONABLY KNOWN/GOOD FAITH EFFORT]{.underline}

A firm must demonstrate that it exercised \"good faith\" in any failed
attempts to obtain required data that is missing, incorrect, or that FDA
considers to be reasonably known. While the concept of good faith is
generally considered to be equivalent to \"due diligence\", CDRH has not
developed a standard. However, the firm\'s procedures for obtaining
missing information should appear under the \"Internal Systems\" section
of its written MDR procedures. In addition, the Center believes that the
parameters of good faith effort must, at a minimum, comport with the
level of risk/nature of the device associated with the event being
investigated.

H. [SERIOUS INJURY]{.underline}

> The interpretation of what constitutes a serious injury can be
> subjective and complicate the enforcement of MDR. The \"unanticipated
> temporary impairment\" part of the former serious injury definition
> has been rescinded, thus alleviating a source of subjectivity. In
> addition, the requirements that intervention be \"immediate\" and the
> concept of \"probability\" have also been removed from the serious
> injury definition.
>
> The current MDR regulation states that a serious injury is an "injury
> or illness.\" This literally means that there has to be an injury that
> is life-threatening, results in permanent impairment/damage, or
> necessitates medical/surgical intervention to preclude permanent
> impairment/damage in order for an event to be reportable as a serious
> injury. If there is no injury attributable to the device, then there
> is no serious injury report, however, the event may qualify as an MDR
> reportable malfunction depending upon the circumstances.
>
> The Center may decide to clarify the definition of serious injury.
> These categories will be provided to the field and the industry
> through MDR guidance documents and/or letters, as necessary.

I. [MALFUNCTIONS]{.underline}

> Malfunction reporting decisions have been the subject of concern by
> both industry and the FDA. Basically, a malfunction is an event that
> is likely to cause or contribute to either a death or serious injury,
> but some circumstance prevented the injury or death from occurring.
> These events are very important since they represent \"potential\"
> deaths or serious injuries and provide the Agency with the opportunity
> to be proactive in reducing risks. Not all malfunctions, however, are
> MDR reportable events.

If a malfunction is not reportable as an MDR, it may be a complaint and
thus subject to the QS/GMP complaint handling requirements. Determining
if an event is a reportable malfunction involves answering a number of
questions including:

1.  Is the event device-related?

2.  Has the device failed to perform its intended function or meet its
    performance specifications?

3.  Is this failure likely to cause or contribute to a death or serious
    injury if the event were to happen again?

There is a presumption in the MDR regulations that if the event happened
once it can happen again. The determination of whether to submit a
report should be based on the potential outcome. For example, if this
malfunction were to occur, how would it affect the patient? If the
answer is \"the malfunction is likely to cause or contribute to death or
serious injury\" then the event is reportable. The preamble to the MDR
regulations (Federal Register: December 11, 1995, Volume 60, Number 237,
pages 63577-63607) offers the following guidance for determining
circumstances in which malfunctions should be reported:

1.  The chance of a death or serious injury occurring as a result of the
    recurrence of the malfunction is not remote;

2.  The consequences of the malfunction affect the device in a
    catastrophic manner that may lead to a death or serious injury;

3.  The malfunction results in the failure of the device to perform its
    intended essential function and compromises the device\'s
    therapeutic, monitoring or diagnostic effectiveness, which could
    cause or contribute to a death or serious injury.

> NOTE: The essential function of a device refers, not only to the
> device\'s labeled use, but for any use widely prescribed within the
> practice of medicine.

4.  The malfunction involves a long-term implant or a device that is
    considered to be life-supporting or life-sustaining and thus is
    essential to maintaining human life. Malfunctions of long-term
    implants are not routinely or \"automatically\" reportable unless
    the malfunction is likely to cause or contribute to a death or
    serious injury if it recurs.

5.  The manufacturer takes or would be required to take an action under
    sections 518 or 519(f) of the Act as a result of the malfunction of
    the device or other similar devices.

Conversely, malfunctions ARE NOT REPORTABLE if they are not likely to
result in a death, serious injury, or another malfunction.

**SOURCES OF INFORMATION**

[WHERE TO OBTAIN MDR FORMS]{.underline}

1.  Consolidated Forms and Publications Office

> Washington Commerce Center
>
> 3222 Hubbard Rd.,
>
> Landover, MD 20785
>
> NOTE: Form FDA 3500A ONLY

2.  Division of Small Manufacturers Assistance

> Office of Health and Industry Programs
>
> Center for Devices and Radiological Health
>
> 1350 Piccard Drive (HFZ 220)
>
> Rockville, MD 20850
>
> NOTE: AVAILABLE ONLY THROUGH FACTS-ON-DEMAND SYSTEM

3.  Food and Drug Administration

> MedWatch (HF-2)
>
> 5600 Fishers Lane, Room 17-65
>
> Rockville, MD 20857
>
> 1-800-FDA-1088 (Press "0" to speak with a staff member) or
> 301-827-7240
>
> NOTE: FORM FDA 3500 ONLY
>
> <http://www.fda.gov/medwatch> and click on \"How to Report\".

4\. Reporting Systems Monitoring Branch

Division of Surveillance Systems

Office of Surveillance and Biometrics

Center for Devices and Radiological Health

1350 Piccard Drive (HFZ-533)

Rockville, MD 20850

NOTE: FDA FORMS 3500A, 3417, and 3419 and instructions for each

> 5\. Web pages
>
> [http://www.fda.gov/cdrh/mdr.html](http://www.fda.gov/cdrg/mdr.html)

The instructions for the Mandatory MedWatch Form, 3500A, are located at
--

> <http://www.fda.gov/medwatch/report/instruc.htm>.

[WHERE TO SUBMIT ALL MANDATORY MDR REPORTS]{.underline}

> Food and Drug Administration
>
> Center for Devices and Radiological Health
>
> PO Box 3002
>
> Rockville, MD 20847-3002

NOTE: Envelopes must be specifically identified with the type of report
enclosed, e.g., Manufacturer Report, User Facility Report, Baseline
Report, Annual Report, Five-Day Report, Supplemental Report, etc.,

[WHERE TO OBTAIN MDR FORMS, GUIDANCE DOCUMENTS OR OTHER MDR
INFORMATION]{.underline}

1.  CDRH Facts-On-Demand, telephone number 1-800-899-0381 or
    301-827-0111. After connecting, follow the recorded instructions.
    The system allows for one request per call. Enter the shelf number
    of choice from the list below followed by the \# (pound) sign and
    continue with the programmed prompts.

###### MDR DOCUMENTS FROM FACTS-ON-DEMAND SYSTEM

> SHELF NO. TITLE
>
> 336# Final MDR Regulation, published 12/11/95
>
> 407# Baseline Report, FDA Form 3417
>
> 409# Annual Report, FDA Form 3419
>
> 799# MDR Related Documents Information
>
> 853# Instructions and Coding Manual for MedWatch 3500A, 77 pages 854#
> MedWatch, FDA Form 3500A
>
> 1061# Instructions for completing FDA Form 3417, Baseline Report
>
> 1096# Stay of effective date for denominator data on Baseline Report
>
> 1336# Amendment to final rule, Federal Register, 4/11/96
>
> 1074# Stay of Certification and U.S. Designated Agent requirements,
> Federal Register, 7/23/96
>
> 1075# Reproposal of Certification requirement, Federal Register,
> 7/23/96.
>
> 1409# Instructions for completing FDA Form 3419, Annual Report
>
> 1853# Coding Manual Addendum

2\. Reporting Systems Monitoring Branch

> Division of Surveillance Systems
>
> Office of Surveillance and Biometrics
>
> Center for Devices and Radiological Health
>
> 1350 Piccard Drive (HFZ-533)
>
> Rockville, MD 20850
>
> ***Fax: 301-837-0008 (specify the documents needed and include your
> address and a phone number where you can be reached) or phone
> 301-594-2735***
>
> 3\. FDA Internet Home Page (HP)

a)  [http://www.fda.gov]{.underline}. - once connected select the CDRH
    icon.

b)  The CDRH home page can be contacted directly using the address
    [http://www.fda.gov/cdrh/]{.underline}.