Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
34
facilities to manually submit MDR reports using
FDA Form 3500A. On 14 August 2014, FDA
also issued guidance, Questions and Answers
about eMDR Electronic Medical Device
Reporting.27 The main objectives of the guidance
were to increase awareness about the process of
submitting MDR incidents to FDA electron-
ically with prior consent from FDA. This rule
became effective on 14 August 2015.
An eMDR submission can be submitted to FDA
through the Electronic Submission Gateway
(ESG) using the following two options: 27
1. Web Interface using the eSubmitter applica-
tion: This is a free, downloadable application
that allows users to create one report at a
time. The eSubmitter program contains
data elements that corresponds to 21 CFR
803.32, 21 CFR 803. 42 and 21 CFR
803.52.
2. Applicability Statement 2 (AS2) Gateway-
to-Gateway using Health Level Seven
(HL7) Individual Case Safety Report
(ICSR) XML: This program allows users to
create and submit eMDRs either individually
or in batches (containing multiple individual
reports in a single submission). Submitters
are required to purchase AS2 system that is
capable of generating HL7ICSR XML and
transmitting it to the ESG.
For a full list of medical device reporting require-
ments, refer to 21 CFR 803.3.23 The following
is a high-level summary of the different types of
medical device reporting requirements:
• Mandatory Reporting: Mandatory reporting
is required by the following:
º Device User Facilities (hospital, ambu-
latory facility, nursing home, outpatient
diagnostic facility or outpatient treat-
ment facility that is not a physician’s
office) (21 CFR 803 Subpart C)
º Importers (21 CFR 803 Subpart D)
º Manufacturer (21 CFR 803 Subpart E)
Table 2-3 lists the details for mandatory report-
ing requirements.
• Voluntary Reporting: Healthcare profes-
sionals, patients, caregivers, and consumers
are encouraged to submit voluntary reports
about serious adverse events, use errors,
product quality issues, and therapeutic
failures to the FDA. Voluntary reporting can
be done online or by submitting FDA Form
3500 (healthcare professional) or FDA Form
3500B (consumer/patient) to MedWatch.25
Please note that voluntary reporting does
not satisfy the obligation to report under 21
CFR 803.
Figure 2-4 provides FDA’s adverse event report-
ing scheme workflow.
In conjunction with the manual reporting
and electronic reporting requirements, FDA
has a database that archives medical device AE
reports submitted to FDA by various aforemen-
tioned mandatory and voluntary reporters. This
is known as the Manufacturer and User Facility
Device Experience (MAUDE) database.28 This
database is public, the reports are redacted, and
data is archived for the last 10 years. Additionally,
this publicly searchable database of adverse event
reports includes user facility reports since 1991,
voluntary reports since 1993, and manufac-
turer reports since August 1996. The MAUDE
database may not include certain reports that are
exempted under 21 CFR 803.19.29
Medical Device Recalls, Corrections,
and Removals30
FDA defines a medical device recall as a method
of removing or correcting products for which
deficiencies are reported in quality, efficacy, or
safety. Recall also includes devices that are in
violation of laws administered by FDA. It is a
voluntary action under 21 CFR 731 conducted
by a manufacturer and distributor to remove
a violative product from the market to pro-
tect the public health. A voluntary recall can
take place any time, and for any reason, by the
manufacturer and distributor or upon FDA
request. FDA’s Office of Regulatory Affairs
(ORA) is responsible for inspecting firms and
enforcing regulations. FDA’s ORA Division
Recall Coordinator (DRC) should be notified
Chapter 2: Postmarket Compliance: US
34
facilities to manually submit MDR reports using
FDA Form 3500A. On 14 August 2014, FDA
also issued guidance, Questions and Answers
about eMDR Electronic Medical Device
Reporting.27 The main objectives of the guidance
were to increase awareness about the process of
submitting MDR incidents to FDA electron-
ically with prior consent from FDA. This rule
became effective on 14 August 2015.
An eMDR submission can be submitted to FDA
through the Electronic Submission Gateway
(ESG) using the following two options: 27
1. Web Interface using the eSubmitter applica-
tion: This is a free, downloadable application
that allows users to create one report at a
time. The eSubmitter program contains
data elements that corresponds to 21 CFR
803.32, 21 CFR 803. 42 and 21 CFR
803.52.
2. Applicability Statement 2 (AS2) Gateway-
to-Gateway using Health Level Seven
(HL7) Individual Case Safety Report
(ICSR) XML: This program allows users to
create and submit eMDRs either individually
or in batches (containing multiple individual
reports in a single submission). Submitters
are required to purchase AS2 system that is
capable of generating HL7ICSR XML and
transmitting it to the ESG.
For a full list of medical device reporting require-
ments, refer to 21 CFR 803.3.23 The following
is a high-level summary of the different types of
medical device reporting requirements:
• Mandatory Reporting: Mandatory reporting
is required by the following:
º Device User Facilities (hospital, ambu-
latory facility, nursing home, outpatient
diagnostic facility or outpatient treat-
ment facility that is not a physician’s
office) (21 CFR 803 Subpart C)
º Importers (21 CFR 803 Subpart D)
º Manufacturer (21 CFR 803 Subpart E)
Table 2-3 lists the details for mandatory report-
ing requirements.
• Voluntary Reporting: Healthcare profes-
sionals, patients, caregivers, and consumers
are encouraged to submit voluntary reports
about serious adverse events, use errors,
product quality issues, and therapeutic
failures to the FDA. Voluntary reporting can
be done online or by submitting FDA Form
3500 (healthcare professional) or FDA Form
3500B (consumer/patient) to MedWatch.25
Please note that voluntary reporting does
not satisfy the obligation to report under 21
CFR 803.
Figure 2-4 provides FDA’s adverse event report-
ing scheme workflow.
In conjunction with the manual reporting
and electronic reporting requirements, FDA
has a database that archives medical device AE
reports submitted to FDA by various aforemen-
tioned mandatory and voluntary reporters. This
is known as the Manufacturer and User Facility
Device Experience (MAUDE) database.28 This
database is public, the reports are redacted, and
data is archived for the last 10 years. Additionally,
this publicly searchable database of adverse event
reports includes user facility reports since 1991,
voluntary reports since 1993, and manufac-
turer reports since August 1996. The MAUDE
database may not include certain reports that are
exempted under 21 CFR 803.19.29
Medical Device Recalls, Corrections,
and Removals30
FDA defines a medical device recall as a method
of removing or correcting products for which
deficiencies are reported in quality, efficacy, or
safety. Recall also includes devices that are in
violation of laws administered by FDA. It is a
voluntary action under 21 CFR 731 conducted
by a manufacturer and distributor to remove
a violative product from the market to pro-
tect the public health. A voluntary recall can
take place any time, and for any reason, by the
manufacturer and distributor or upon FDA
request. FDA’s Office of Regulatory Affairs
(ORA) is responsible for inspecting firms and
enforcing regulations. FDA’s ORA Division
Recall Coordinator (DRC) should be notified