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FDA Approval
The FDA’s Post-Market Surveillance Requirements for Reagents and POCT Devices

As a manufacturer of reagents and point-of-care testing (POCT) devices, you will be well aware of the rigorous pre-market requirements required by the FDA. However, it is equally important to be aware of the post-market surveillance requirements that the FDA imposes on medical device manufacturers.

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By
Jack Purvis
Published on
July 12, 2023
Updated on
April 20, 2023
Table of Contents

Post-market surveillance

Post-market surveillance refers to the process of monitoring and reporting on the safety and effectiveness of medical devices once they are on the market. This is an essential aspect of the regulatory process, as it allows the FDA to identify and respond to any safety issues that may arise with a device.

In the case of reagents and POCT devices, the FDA's post-market surveillance requirements include the following:

  1. Reporting of adverse events: Medical device manufacturers are required to report any adverse events related to their devices to the FDA. This includes events such as malfunctions, injuries, or deaths that are associated with the use of the device.
  1. Complaint handling: Manufacturers must establish and maintain a system for handling complaints about their devices. This system must include procedures for evaluating complaints, investigating any problems that are identified, and taking appropriate corrective action.
  1. Quality system regulation: Manufacturers must comply with the FDA's Quality System Regulation (QSR), which requires them to establish and maintain a quality system for the design, manufacture, and distribution of medical devices.
  1. Post-market surveillance studies: The FDA may require manufacturers to conduct post-market surveillance studies to assess the safety and effectiveness of their devices. These studies may be required for specific devices or for a class of devices.
  1. Device tracking: Some medical devices, including some reagents and POCT devices, may be subject to device tracking requirements. This means that manufacturers must establish procedures for tracking the devices through the distribution chain and maintaining records of where the devices have been shipped.

Complying with the FDA's post-market surveillance requirements can be a complex and challenging process. However, it is an essential aspect of bringing safe and effective medical devices to market. By staying informed of the requirements and implementing appropriate processes and procedures, manufacturers can help ensure the ongoing safety and effectiveness of their reagents and POCT devices.