eCFR :: 21 CFR Part 822 -- Postmarket Surveillance
This part implements section 522 of the Federal Food, Drug, and Cosmetic Act by providing procedures and requirements for postmarket surveillance of class II and class III devices that meet any of the following criteria: (a) Failure of the device would be reasonably likely to have serious adverse health consequences;
FDA Post-Market Surveillance (PMS) for Medical Devices | OMC
FDA Post-Market Surveillance (PMS) is a regulatory requirement under 21 CFR Part 822, designed to ensure the long-term safety and effectiveness of medical devices after they have been released into the market.
Medical Device Post-Market Surveillance (PMS) - SimplerQMS
Feb 28, 2025 · Post-Market Surveillance (PMS) for medical devices is a systematic process of monitoring device performance, safety, and effectiveness after they have been placed on the market. PMS is required by various regulatory requirements, including the FDA 21 CFR Part 822, ISO 13485, and EU MDR.
Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance...
Post-Market Surveillance (PMS) and Vigilance: US & EU Guide
May 16, 2024 · FDA’s post market surveillance requirements for Class II and III devices are addressed in 21 CFR Part 822 – Post market Surveillance. Part 822 applies to devices that meet these criteria: Failure of the device would be reasonably likely …
Understanding Post-Market Surveillance Requirements for …
Feb 9, 2020 · For more information, you can view 21 CFR Part 822, which details the requirements for PMS in the US. The FDA has government authorization to require post-market surveillance for class II and class III medical devices that meet one of four criteria:
Post-Market Surveillance and monitoring of devices on the market
Jan 6, 2022 · Post-Market Surveillance (PMS) is a proactive and systematic process to derive necessary corrective and preventive actions (CAPA) from information about medical devices already placed on the market. We have created a Post-Market Surveillance checklist for you.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file …
Postmarket Surveillance of Medical Devices: Ultimate Guide
Feb 26, 2023 · Comprehensive overview of postmarket surveillance (PMS) of medical devices, covering the different regulations and providing best practices and tips for carrying out PMS activities.
21 CFR Part 822: Postmarket Surveillance - - a visual approach to ...
Postmarket surveillance (PMS) is the process of monitoring the safety and effectiveness of medical devices after they have been approved or cleared for marketing by the FDA. PMS can help identify unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect the public health when using a ...