Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring that they continue to monitor the safety/effectiveness of the manufactured devices that are on the market. The requirement for post-market surveillance (PMS) was implemented so that manufacturers understood that their device is still their responsibility even after it has left their manufacturing site and entered the market. PMS is intended to be a reporting system that manufacturers can utilize to continuously monitor device performance and learn from any mistakes such as adverse events.
Every manufacturer that has a medical device on the US market is familiar with 21 CFR Part 820, the Quality System Regulation (QSR). Although the QSR details all the requirements for firms to develop and manufacturer medical devices, there is no mention of post-market surveillance; instead, manufacturers will have to look to 21 CFR part 822 for details on requirements for PMS. Part 822 is in alignment with Section 522 of the Federal Food, Drug, and Cosmetic Act that provides the FDA with the authority to require manufacturers to conduct post-market surveillance of certain Class II or Class III devices.1
If your Class II or Class III device is intended to be implanted in the body for over a year, the device is a life-supporting device used outside of a user facility, or if failure of your device would be reasonably likely to have serious adverse health consequences, the FDA can require post-market surveillance of your device. PMS can be ordered in response to adverse event reports, or to obtain more information on how a device performs in real-world clinical practice. Whenever post-market surveillance is ordered by the FDA, the manufacturer must submit a PMS plan. Elements of a PMS plan include, but are not limited to, the background of the device, description of data collection procedures/statistical analysis, and timelines.2
PMS is not exclusive to the United States, there are also requirements to maintain a PMS system in both the EU MDR and ISO 13485:2016. Although the requirements differ, the basic principle of post-market surveillance for all markets is to protect public health and allow manufacturers to identify areas for improvement in clinical practice. If you need help developing a PMS plan or ensuring compliance with PMS requirements, EMMA International’s team of quality and regulatory experts are ready to help. Give us a call at 248-987-4497 or email firstname.lastname@example.org for more information.
1FDA (May 2016) Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act retrieved on 10/4/2020 from: https://www.fda.gov/media/81015/download
2FDA (September 2018) 522 Postmarket Surveillance Studies – FAQ’s retrieved on 10/4/2020 from: https://www.fda.gov/medical-devices/522-postmarket-surveillance-studies/522-postmarket-surveillance-studies-frequently-asked-questions-faqs