Postmarket Requirements for Medical Devices: A Practical Guide
3
Introduction
In the US, the legislative requirements set forth
in Section 522 of the Food, Drug, and Cosmetics
Act (FD&C Act) mandate postmarket surveil-
lance for medium (Class II) and high-risk (Class
III) medical devices. The US Food and Drug
Administration’s (FDA) Center for Devices and
Radiological Health (CDRH) is responsible for
protecting and promoting the public health by
ensuring timely and continued access to safe,
effective, and high-quality medical devices and
safe radiation-emitting products for healthcare.1
In general, postmarket surveillance refers
to the monitoring process for legally marketed
medical products, which constitutes an active,
systematic, and scientifically valid collection of
data related to their intended clinical use, data
analysis, and its interpretation for safety and
performance outcomes. In this process, the mon-
itoring of postmarket product-related adverse
events (AEs), including their frequency, occur-
rence, and severity, applies to any product-related
safety concerns, public health impact, and justifi-
cation for a medical device’s safety, performance,
and efficacy.
FDA requirements for medical device
reporting were enacted in December 1984.
However, the US Congress first granted FDA
the authority to enforce and require certain med-
ical device manufacturers to conduct postmarket
surveillance, per Section 522 of the Safe Medical
Devices Act (SMDA) of 1990. The SMDA
further provided FDA with two additional post-
market activities, including:
1. Postmarket surveillance for the monitoring
of products after their market clearance
2. Device tracking for maintaining traceability
of certain devices to the user level
Section 212 of the Food and Drug
Modernization Act (FDAMA) of 1997 further
amended the Section 522 in part to stipulate that
the postmarket surveillance may be required by
order for any Class II or Class III device the fail-
ure of which would be reasonably likely to have
serious adverse health consequences, which is
intended to be implanted in the human body for
more than one year, or which is a life-sustaining
or life-supporting device used outside a device
user facility.2-4
Under Section 212 of FDAMA, FDA is
authorized to require a prospective surveillance
period of up to 36 months, unless FDA deter-
mines a longer period is necessary, and there
is a mutual agreement between FDA and the
Postmarket Compliance
and Product Changes: US
By Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global
1
3
Introduction
In the US, the legislative requirements set forth
in Section 522 of the Food, Drug, and Cosmetics
Act (FD&C Act) mandate postmarket surveil-
lance for medium (Class II) and high-risk (Class
III) medical devices. The US Food and Drug
Administration’s (FDA) Center for Devices and
Radiological Health (CDRH) is responsible for
protecting and promoting the public health by
ensuring timely and continued access to safe,
effective, and high-quality medical devices and
safe radiation-emitting products for healthcare.1
In general, postmarket surveillance refers
to the monitoring process for legally marketed
medical products, which constitutes an active,
systematic, and scientifically valid collection of
data related to their intended clinical use, data
analysis, and its interpretation for safety and
performance outcomes. In this process, the mon-
itoring of postmarket product-related adverse
events (AEs), including their frequency, occur-
rence, and severity, applies to any product-related
safety concerns, public health impact, and justifi-
cation for a medical device’s safety, performance,
and efficacy.
FDA requirements for medical device
reporting were enacted in December 1984.
However, the US Congress first granted FDA
the authority to enforce and require certain med-
ical device manufacturers to conduct postmarket
surveillance, per Section 522 of the Safe Medical
Devices Act (SMDA) of 1990. The SMDA
further provided FDA with two additional post-
market activities, including:
1. Postmarket surveillance for the monitoring
of products after their market clearance
2. Device tracking for maintaining traceability
of certain devices to the user level
Section 212 of the Food and Drug
Modernization Act (FDAMA) of 1997 further
amended the Section 522 in part to stipulate that
the postmarket surveillance may be required by
order for any Class II or Class III device the fail-
ure of which would be reasonably likely to have
serious adverse health consequences, which is
intended to be implanted in the human body for
more than one year, or which is a life-sustaining
or life-supporting device used outside a device
user facility.2-4
Under Section 212 of FDAMA, FDA is
authorized to require a prospective surveillance
period of up to 36 months, unless FDA deter-
mines a longer period is necessary, and there
is a mutual agreement between FDA and the
Postmarket Compliance
and Product Changes: US
By Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global
1