Postmarket Requirements for Medical Devices: A Practical Guide
33
• A manufacturer is considered to have
“become aware” of an event in the following
scenarios:
º A device user facility is considered to
have “become aware” when medical
personnel who are employed by or oth-
erwise formally affiliated with a facility
obtain information about a reportable
event.
º A manufacturer is considered to have
“become aware” of an event when an
employee with management or super-
visory responsibilities over persons
with regulatory, scientific, or technical
responsibilities or whose duties include
the collection and reporting of adverse
events becomes aware of any infor-
mation (including any trend analysis)
that an MDR reportable event requires
remedial action to prevent an unrea-
sonable risk of substantial harm to the
public health. In this case, the event
is required to be reported within five
workdays.
º A manufacturer is considered to have
“become aware” of an event when any
employee becomes aware of a reportable
event that is required to be reported
within 30 calendar days or that is
required to be reported within five
workdays.
º An importer is considered to have
“become aware” of an event when any
employee becomes aware of a reportable
event that is required to be reported
within 30 calendar days.
• “Caused or contributed” to a death or serious
injury means a death or serious injury was
or may have been attributed to a medical
device, or that a medical device was or may
have been a factor in a death or serious injury,
including events occurring as a result of:
º Failure
º Malfunction
º Improper or inadequate design
º Manufacture
º Labeling
º User error
• “Serious injury” means an injury or illness
that:
º Is life-threatening
º Results in permanent disability, such as
permanent damage to a body structure
or permanent impairment of a body
function
º Requires medical intervention to pre-
clude permanent impairment of a body
structure. Permanent means irrevers-
ible impairment or damage to a body
structure or function excluding trivial
impairment or damage
• “Malfunctions” means the failure of a device
to meet its performance specifications or
otherwise perform as intended. Performance
specifications include all claims made in
the labeling of a device. An MDR submis-
sion is required for a marketed device if a
device malfunctioned or is likely to cause or
contribute to a death or serious injury. MDR
reporting to FDA is governed by a PMS
program known as MedWatch.24 All MDRs
are required to be in the English language.
An MDR submission should be made to
FDA using the following forms:25
º Form FDA 3500: Voluntary Reporting
for healthcare professionals (https://
www.fda.gov/media/76299/download)
º Form FDA 3500 A: Mandatory
Reporting (https://www.fda.gov/
media/82655/download)
º Form FDA 3500B: Voluntary Reporting
for consumers/patients (https://accessi-
ble-techcomm.org/wp-content/uploads/
MedWatch_Consumer_Voluntary_
Reporting_form-FDA-3500B.pdf)
º Form 3419: Medical Device Reporting
Annual User Facility Report (C:\Users\
maliks2\Downloads\FDA_3419_12-
13-18.pdf)
On 14 February 2014, FDA published a final
rule on electronic medical device reporting
(eMDR),26 requiring manufacturers and import-
ers to submit MDRs to FDA in an electronic
format for their review, process, and archival
purposes. User facilities also can submit electron-
ically however, the final rule still permits user
33
• A manufacturer is considered to have
“become aware” of an event in the following
scenarios:
º A device user facility is considered to
have “become aware” when medical
personnel who are employed by or oth-
erwise formally affiliated with a facility
obtain information about a reportable
event.
º A manufacturer is considered to have
“become aware” of an event when an
employee with management or super-
visory responsibilities over persons
with regulatory, scientific, or technical
responsibilities or whose duties include
the collection and reporting of adverse
events becomes aware of any infor-
mation (including any trend analysis)
that an MDR reportable event requires
remedial action to prevent an unrea-
sonable risk of substantial harm to the
public health. In this case, the event
is required to be reported within five
workdays.
º A manufacturer is considered to have
“become aware” of an event when any
employee becomes aware of a reportable
event that is required to be reported
within 30 calendar days or that is
required to be reported within five
workdays.
º An importer is considered to have
“become aware” of an event when any
employee becomes aware of a reportable
event that is required to be reported
within 30 calendar days.
• “Caused or contributed” to a death or serious
injury means a death or serious injury was
or may have been attributed to a medical
device, or that a medical device was or may
have been a factor in a death or serious injury,
including events occurring as a result of:
º Failure
º Malfunction
º Improper or inadequate design
º Manufacture
º Labeling
º User error
• “Serious injury” means an injury or illness
that:
º Is life-threatening
º Results in permanent disability, such as
permanent damage to a body structure
or permanent impairment of a body
function
º Requires medical intervention to pre-
clude permanent impairment of a body
structure. Permanent means irrevers-
ible impairment or damage to a body
structure or function excluding trivial
impairment or damage
• “Malfunctions” means the failure of a device
to meet its performance specifications or
otherwise perform as intended. Performance
specifications include all claims made in
the labeling of a device. An MDR submis-
sion is required for a marketed device if a
device malfunctioned or is likely to cause or
contribute to a death or serious injury. MDR
reporting to FDA is governed by a PMS
program known as MedWatch.24 All MDRs
are required to be in the English language.
An MDR submission should be made to
FDA using the following forms:25
º Form FDA 3500: Voluntary Reporting
for healthcare professionals (https://
www.fda.gov/media/76299/download)
º Form FDA 3500 A: Mandatory
Reporting (https://www.fda.gov/
media/82655/download)
º Form FDA 3500B: Voluntary Reporting
for consumers/patients (https://accessi-
ble-techcomm.org/wp-content/uploads/
MedWatch_Consumer_Voluntary_
Reporting_form-FDA-3500B.pdf)
º Form 3419: Medical Device Reporting
Annual User Facility Report (C:\Users\
maliks2\Downloads\FDA_3419_12-
13-18.pdf)
On 14 February 2014, FDA published a final
rule on electronic medical device reporting
(eMDR),26 requiring manufacturers and import-
ers to submit MDRs to FDA in an electronic
format for their review, process, and archival
purposes. User facilities also can submit electron-
ically however, the final rule still permits user