Medical Device
Reporting (MDR)
Requirements for ACME Device Company
Presented by: Dawn Fernandes – Safis Solutions, LLC
Objectives
• Understand the regulatory requirements for
Medical Device Reporting (MDR) that apply to
manufacturers
• Know what constitutes a reportable event
• Understand the steps and time frames of the
reporting process
• Understand what happens with this data after
a report is made
Regulatory Requirements for Medical Device
Reporting (MDR)
According to 21 CFR 803, the following parties
must submit MDRs to the FDA:
• Manufacturers
• Importers
• Device User Facilities
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Hospitals
Outpatient Diagnostic Facilities
Outpatient Treatment Facilities
Nursing Homes
Requirements for Manufacturers
ACME is a manufacturer, as by definition a
manufacturer is:
Any person who manufacturers, prepares, assembles, or
processes a device by chemical, physical, biological, or
other procedure, including:
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Domestic Manufacturers
Repackagers
Relabelers
Contract manufacturers
Specification Developers
U.S. Agents of Foreign Manufacturers
Requirements for Manufacturers
Manufacturers must submit the following
reports to the FDA:
• Reports of individual adverse events no later than 30
calendar days after becoming aware of a reportable
death, serious injury, or malfunction.
• Reports of individual adverse events no later than 5
work days after becoming aware of:
• A reportable event that requires remedial action to
prevent an unreasonable risk of substantial harm to the
public health,
or
• A reportable event for which the FDA has made a written
request.
Requirements for Manufacturers
Manufacturers must submit the following
reports to the FDA:
• Supplemental reports - should you obtain further
information concerning an event that was not
submitted in an initial report.
Requirements for Manufacturers
Manufacturers must also:
• Establish MDR procedures (21 CFR Part 803.17)
• Establish and maintain MDR event files (21 CFR Part
803.18)
Requirements for Manufacturers
Additionally, both 21 CFR 803 and 21 CFR 820
require manufacturers to investigate events:
Sec. 820.198 Complaint files (d)
• Any complaint representing a reportable event must be:
• promptly reviewed, evaluated, and investigated by a
designated individual(s)
• must be maintained in a separate portion of the complaint files
or otherwise clearly identified.
Sec. 803.50 (b) (3)
• Manufacturers are also responsible for conducting an
investigation of each event and evaluating the cause of the
event.
Requirements for Manufacturers
Additionally, both 21 CFR 803 and 21 CFR 820
require manufacturers to investigate events:
• Any complaint representing a reportable event must be:
• promptly reviewed, evaluated, and investigated by a
designated individual(s)
• must be maintained in a separate portion of the complaint files
or otherwise clearly identified.
• Investigations must include a determination of:
• whether the device failed to meet specifications;
• whether the device was being used for treatment or diagnosis;
and
• the relationship, if any, of the device to the reported incident or
adverse event.
What is a ‘Reportable Event’?
An event that a manufacturer becomes aware of
that reasonably suggests that one of their
marketed devices:
• May have caused or contributed to a death or serious
injury,
or
• Has malfunctioned and that the device or a similar
device marketed by the manufacturer would be likely
to cause or contribute to a death or serious injury if
the malfunction were to recur.
Clarify ‘Serious Injury”
A reportable serious injury is defined as an
injury or illness that is:
• life-threatening,
• Results in permanent impairment of a body function or
permanent damage to a body structure;
or
• Necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent
damage to a body structure
Permanent means irreversible impairment or
damage to a body structure or function, excluding
trivial impairment or damage.
Clarify ‘Malfunction’
Malfunction is the failure of a device to meet its
performance specifications or otherwise
perform as intended.
• Performance specifications include all claims made in
the labeling for the device
• Intended performance refers to intended use for
which the device is labeled or marketed
If the malfunction of a device or a similar device is
likely to cause or contribute to a reportable death
or serious injury if it were to recur, the event is
reportable to the FDA
‘Reasonably Suggests’?
Information that reasonably suggests that a reportable
event has occurred includes professional, scientific or
medical facts, observations and/or opinions that would
logically imply that a device has caused or may have caused
or contributed to a reportable event.
Caused or contributed means a medical device was or may
have been a factor in a reportable death or serious injury, or a
death or serious injury was or may have been attributed to a
medical device, including events resulting from:
• Failure
• Manufacturing issues
• Malfunction
• Labeling issues
• User Error
• Improper / Inadequate design
How do I ‘become aware’?
Become aware means that an ACME employee has
acquired information that reasonably suggests a
reportable adverse event has occurred.
Manufacturers are considered to have become aware
when:
• Any employee becomes aware of an event
• Any employee with management/supervisory
responsibilities or responsibility to collect and report
adverse events becomes aware that a reportable MDR
event(s) necessitates remedial action to prevent an
unreasonable risk of substantial harm to the public
health.
How do I ‘become aware’?
Information concerning potentially reportable
adverse events comes from both internal and
external sources.
• Internal
• Trend Analysis
• e.g., stability testing results
• External
• Customer Complaints
• FDA notification/request
The applicable ACME procedures should be followed
for timely communication of potentially reportable
events from all sources.
We’ve become aware - now what?
Per the ACME procedure on Medical Device
Reporting:
• Designated individuals will review and evaluate
the details of the adverse event to determine if it
meets the threshold for a reportable event:
• Quickly - time is of the essence.
• According to a defined, standardized process.
• Documenting all information that was evaluated
and the rationale used in determining if a death,
serious injury or malfunction was or was not
reportable.
We’ve become aware - now what?
If the FDA has not made a written request for 5 day
reports for the event, and the designated
individuals have determined the event to be
reportable, the required reporting timeframe is
determined:
• 5 working days for reportable events requiring
remedial action to prevent risk of substantial harm to
the public health,
or
• 30 calendar days for all other initial reports
We’ve become aware - now what?
Per the ACME procedure on Medical Device
Reporting, an Investigation will be initiated.
• Investigations must include a determination of:
• whether the device failed to meet specifications;
• whether the device was being used for treatment or
diagnosis; and
• the relationship, if any, of the device to the reported
incident or adverse event.
We’ve become aware - now what?
Per the ACME procedure on Medical Device
Reporting:
• Potential impact and risk will be evaluated by
designated individuals to determine the need for
containment activities. This may include:
• Internal Containment activities (21 CFR 820.90)
• Product holds
• Inventory reconciliation (scrapping bad product)
• External Containment activities (21 CFR 803)
• Corrections
• Removals
Containment Activities
• Product Holds
• the quarantine of product still within the inventory
or control of the manufacturer.
• Correction
• 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.
• Removal (a.k.a. Recall)
• the physical removal of a device from its point of use
to some other location for repair, modification,
adjustment, relabeling, destruction, or inspection.
Completing the Report
• The report must be forwarded using FDA MEDWATCH
Form 3500A or an electronic equivalent as provided
for under Part 803.14.
• Forms may be obtained from any of the following
resources:
• The Consolidated Forms and Publications Office, Beltsville
Service Center, 6351 Ammendale Rd., Landover, MD 20705;
• FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD
20857, 301-827-7240;
• FDA, Center for Devices and Radiological Health, Division of
Small Manufacturers, International and Consumer Assistance,
10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring,
MD 20993-0002.
• On the Internet at
http://www.fda.gov/medwatch/getforms.htm
Completing the Report
Manufacturers are required to report the information
listed in 21 CFR Part 803.52, including:
• Patient information (Form 3500A, Block A)
• Information concerning the adverse event or product
problem (Form 3500A, Block B); including outcomes
attributed to the adverse event (e.g., death, serious injury)
• Device information (Form 3500A, Block D), including
device description, manufacturer information,
implantation/explantation dates, etc.
• Initial reporter information (Form 3500A, Block E).
• Reporting contact information for all manufacturers (Form
3500A, Block G).
• Device manufacturer information (Form 3500A, Block H).
Completing the Report
The Device manufacturer information (Form 3500A,
Block H) required includes:
• Type of reportable event (death, serious injury,
malfunction, etc.);
• Type of follow-up report, if applicable (e.g., correction,
response to FDA request, etc);
• Summary of the evaluation of returned device. If an
evaluation was not performed, explain why this was
not done
• Device manufacture date (month, day, year);
• Whether the device was labeled for single use;
Completing the Report
The Device manufacturer information (Form 3500A,
Block H) required includes:
• Evaluation codes: event codes, method of evaluation,
result, and conclusion codes (see FDA MEDWATCH
Medical Device Reporting Code Instructions);
• Whether remedial action was taken and the type of
action;
• Whether the use of the device was initial, reuse, or
unknown;
• Whether remedial action was reported as a removal or
correction under section 519(f) of the act, and if so,
provide the correction/removal report number
Where to send the Report
FDA/CDRH
Medical Device Reporting
P.O. Box 3002
Rockville, MD 20847
20847-3002
Indicate on the envelope that it is a Manufacturer:
• Initial Report
• 5-day Report
or
• Supplemental Report, as applicable
Reporting Expectations
Manufacturers are responsible for:
• providing all information reasonably known to
them
• conducting an investigation of each event
• evaluating the cause of each event
• obtaining and providing missing information
• explaining why information is incomplete
Required information obtained after the initial
report filing must be provided in a
supplemental report.
Reporting Expectations
All information reasonably known about the
event includes:
• Any information that can be obtained by contacting
the reporter
• Any information in your possession
or
• Any information that can be obtained by analysis,
testing or other evaluation
Supplemental Reports
A Supplemental Report should be submitted:
• Whenever new information is acquired that was not
provided in the initial MDR
• Within 30 calendar days from receipt of the new
information
• Using Form 3500A, indicating that report is a
supplement
Provide the Manufacturer Report Number from the
initial MDR; and, only complete those blocks of
Form 3500A that are changing.
Exemptions
Per Part 803.19, Manufacturers can request
exemptions to reporting requirements. For
example:
• Alternative Summary Reporting (ASR) – a subset of
the information required for FDA Form 3500A
• Total Exemption - for specific device and/or patient
related events
• Remedial Action Exemption (RAE) - for recalled
products covered by 21 CFR Part 806 (Corrections and
Removals)
• Exemption to submit a single MDR for one event
where both Manufacturer and Importer have
reporting responsibilities and requirements
When not to report
An MDR is not required:
• In cases of erroneous information, where a devicerelated event did not actually occur
• When it is determined that the device in question was
manufactured by another firm
However, when a manufacturer receives this type of
report, they should forward the report to FDA with an
explanatory cover letter.
MDR Event Files
Manufacturers must establish and maintain MDR event
files. The files may be written or electronic and may
refer to other information/files .
Files must contain:
• Information in manufacturer’s possession or references to
information related to the event
• Documentation of decision making processes used to
determine if a death, serious injury or malfunction
was/was not reportable
• Copies of MDR forms and other information reported to
FDA
• An explanation of why information was not/could not be
submitted to the FDA
• Results of evaluations of each event
MDR Record Retention
Manufacturers must retain MDR event files for
the greater of:
• 2 years from the date of the adverse event;
or
• a period of time equivalent to the expected life of the
associated device
If a device is no longer distributed, MDR event files must
be maintained for the time periods described above.
Manufacturers, like ACME, may maintain MDR event
files within the Complaint files; however, they must be
prominently identified as MDR reportable events.
How is MDR information used?
Event reports are analyzed by FDA staff, including
health care clinicians, engineers and scientists.
Follow -up actions that the FDA may take include:
• Requests for additional information
• Conducting an investigation of event
• Conducting an inspection at the manufacturer,
importer or user facility
• Contacting the manufacturer about a recall
• Issuing a public health advisory/safety alert
How is MDR information used?
Redacted versions of medical device reports
submitted to the FDA by mandatory
reporters (manufacturers, importers and device
user facilities) and voluntary reporters such as
health care professionals, patients and consumers,
are made publicly available via the MAUDE
(Manufacturer and User Facility Device Experience)
database on the CDRH web page.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/sea
rch.CFM
Questions?
Activity time
Please read through your assigned scenario and discuss
with the other participants at your table.
As a group, determine whether you believe the event to
be a reportable adverse event. Provide your rationale as
to why your group believes that the event is, or is not,
reportable.