Postmarket Requirements for Medical Devices: A Practical Guide
vii
Foreword
Postmarket surveillance is the active and systematic review of scientifically valid collection, analysis, and inter-
pretation of data or other information about a marketed and commercially available medical device, including
in vitro diagnostics (IVDs). This is a crucial tool to ensure medical devices, which tend to be dynamic and con-
tinuously evolving, are safe and the benefits of continued use outweigh any risks. Medical device manufacturers,
as well as other firms involved in the distribution of devices, must follow certain requirements and regulations
once devices are on the market, including as applicable postmarket surveillance studies (for example as required
under Section 522 of the Federal Food, Drug and Cosmetic Act [FD&C Act])] or post-approval studies (for
example, as required at the time of approval of a premarket approval [PMA], humanitarian device exemption
[HDE], or product development protocol [PDP] application).
As an indication of the importance of evaluating medical devices throughout the total product lifecycle
(TPLC), the establishment of the National Evaluation System for health Technology (NEST) was a 2016-
2017 strategic priority for the US Food and Drug Administration (FDA), Center for Devices and Radiological
Health (CDRH) to generate better evidence more efficiently, strategically, and systematically, for medical
device evaluation and regulatory decision-making. While NEST is currently focused on real-world use of
devices in the US, harmonization efforts with other global regulatory efforts have begun. The medical device
sector is complex, with evolving and iterative technology development and continuous innovation, which
makes managing postmarket reporting more challenging due to constant product changes to ensure products
are safe and effective for use patients.
In addition, the last few years has brought increased attention to ensuring adequate postmarket sur-
veillance in monitoring the safety and performance of medical devices once marketed. FDA, in October
2022, released the final guidance, Postmarket Surveillance under Section 522 of the Federal Food, Drug, and
Cosmetic Act: Guidance for Industry and the Food and Drug Administration Staff to assist medical device
manufacturers in fulfilling their obligations of the postmarket surveillance orders under Section 522 of the
FD&C Act, as required. The European Union Medical Device Regulation 2017/745 (EU MDR) and In Vitro
Medical Device Regulation 2017/746 (EU IVDR) represented significant changes to the EU legislation of
medical devices and IVDs, especially in the postmarket stage for safety and performance, with the compliance
timelines being May 2021 and May 2022, respectively. In addition, there has been increased global attention on
the use of real-world evidence for postmarket surveillance of medical devices.
As the Head of NEST, this new RAPS book, Postmarket Requirements for Medical Devices: A Practical
Guide, is a timely publication and provides all the necessary information for creating a program for meeting
global medical device postmarket regulations. It is a “must-have” as part of the regulatory arsenal toolkit for
any regulatory professional in the medical device sector. I congratulate all contributors for their dedication to
producing a high-quality practical guide covering the global market on medical devices focusing on emerging
issues in postmarket surveillance to ensure patients have access to safe and effective health technologies.
Flora Sandra Siami, MPH
Senior Vice President, Medical Device Innovation Consortium (MDIC)
Head, National Evaluation System for health Technology (NESTcc)
vii
Foreword
Postmarket surveillance is the active and systematic review of scientifically valid collection, analysis, and inter-
pretation of data or other information about a marketed and commercially available medical device, including
in vitro diagnostics (IVDs). This is a crucial tool to ensure medical devices, which tend to be dynamic and con-
tinuously evolving, are safe and the benefits of continued use outweigh any risks. Medical device manufacturers,
as well as other firms involved in the distribution of devices, must follow certain requirements and regulations
once devices are on the market, including as applicable postmarket surveillance studies (for example as required
under Section 522 of the Federal Food, Drug and Cosmetic Act [FD&C Act])] or post-approval studies (for
example, as required at the time of approval of a premarket approval [PMA], humanitarian device exemption
[HDE], or product development protocol [PDP] application).
As an indication of the importance of evaluating medical devices throughout the total product lifecycle
(TPLC), the establishment of the National Evaluation System for health Technology (NEST) was a 2016-
2017 strategic priority for the US Food and Drug Administration (FDA), Center for Devices and Radiological
Health (CDRH) to generate better evidence more efficiently, strategically, and systematically, for medical
device evaluation and regulatory decision-making. While NEST is currently focused on real-world use of
devices in the US, harmonization efforts with other global regulatory efforts have begun. The medical device
sector is complex, with evolving and iterative technology development and continuous innovation, which
makes managing postmarket reporting more challenging due to constant product changes to ensure products
are safe and effective for use patients.
In addition, the last few years has brought increased attention to ensuring adequate postmarket sur-
veillance in monitoring the safety and performance of medical devices once marketed. FDA, in October
2022, released the final guidance, Postmarket Surveillance under Section 522 of the Federal Food, Drug, and
Cosmetic Act: Guidance for Industry and the Food and Drug Administration Staff to assist medical device
manufacturers in fulfilling their obligations of the postmarket surveillance orders under Section 522 of the
FD&C Act, as required. The European Union Medical Device Regulation 2017/745 (EU MDR) and In Vitro
Medical Device Regulation 2017/746 (EU IVDR) represented significant changes to the EU legislation of
medical devices and IVDs, especially in the postmarket stage for safety and performance, with the compliance
timelines being May 2021 and May 2022, respectively. In addition, there has been increased global attention on
the use of real-world evidence for postmarket surveillance of medical devices.
As the Head of NEST, this new RAPS book, Postmarket Requirements for Medical Devices: A Practical
Guide, is a timely publication and provides all the necessary information for creating a program for meeting
global medical device postmarket regulations. It is a “must-have” as part of the regulatory arsenal toolkit for
any regulatory professional in the medical device sector. I congratulate all contributors for their dedication to
producing a high-quality practical guide covering the global market on medical devices focusing on emerging
issues in postmarket surveillance to ensure patients have access to safe and effective health technologies.
Flora Sandra Siami, MPH
Senior Vice President, Medical Device Innovation Consortium (MDIC)
Head, National Evaluation System for health Technology (NESTcc)