The realm of medical devices is one of constant innovation and advancement. However, the journey of a medical device does not end with its entry into the market. Post-market Surveillance (PMS) and reporting are critical components of a device’s lifecycle, which ensure ongoing safety and efficacy for end-users. To address this, the United States Food and Drug Administration (US FDA) has established stringent PMS requirements to protect public health. This blog will explore the importance of these processes and outline the US FDA’s requirements and best practices for medical device manufacturers.

The Importance of PMS

PMS involves the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information on marketed medical devices. It serves several vital functions, such as:

• Identifying Adverse Events: PMS helps detect and monitor adverse events or device malfunctions that may not have been apparent during pre-market testing.
• Assessing Long-term Performance: PMS provides data on the long-term safety and efficacy of devices, especially those that are implantable or life-sustaining.
• Informing Regulatory Actions: The information gathered can lead to Regulatory actions such as recalls, safety communications, or changes to labeling.
• Guiding Clinical Practice: Real-world data from PMS can influence clinical guidelines and the use of devices.

The US FDA’s PMS Requirements

The US FDA mandates that PMS must be conducted for certain Class II or Class III medical devices to address public health concerns concerning safety and efficacy. The requirements include:

• PMS Plans: Manufacturers must submit PMS plans that outline the methodology for data collection and analysis.
• Timely Reporting: Manufacturers should submit an interim report within the timeframe given in the PMS plan, and the final report no later than three (03) months after the completion of the study.
• Content of PMS Reports: PMS reports must contain specific information that will help the US FDA identify a specific device, the PMS being conducted, its status, and any reasons for delays or incomplete surveillance.
• The US FDA’s Actions: Based on the PMS data, the US FDA may request the manufacturer for labeling changes, issue new surveillance orders, or take other Regulatory actions to protect public health.

The US FDA may issue a new PMS order in several circumstances, including but not limited to, the following:

• If the results of the ongoing PMS raise new issues or questions about a device’s safety or efficacy.
• To better understand the nature, severity, or frequency of the suspected problems reported in adverse event reports or in published literature.
• To obtain more information on device performance, associated with real-world clinical practice.
• To address long-term or infrequent issues related to safety and efficacy in implantable and other devices, for which pre-market testing provided only limited information.
• When unexpected or unexplained serious adverse events occur after a device has been marketed, if there is an increase in the severity of adverse events, or if there is an increase in the frequency of serious adverse events.
• If there is a need to better define the association between problems and devices.
• If PMS needs to be conducted to assess the efficacy of the device in detecting or treating a disease or condition, rather than the surrogate initially used for pre-market evaluation.

Best Practices for PMS and Reporting

To comply with the US FDA’s requirements and ensure the efficacy of PMS and reporting, manufacturers should adopt these best practices:

• Develop a Comprehensive Plan: A robust PMS plan should include clear objectives, methodologies, and timelines for data collection and reporting.
• Ensure Quality Data Collection: Manufacturers should collect data actively and systematically to ensure that it is scientifically valid and reliable.
• Maintain Open Communication: Manufacturers should engage in ongoing dialogue with the US FDA, especially if new safety issues arise or if there are changes in the surveillance status.
• Promptly Address Identified Issues: Manufacturers should promptly address any problems or adverse events identified through surveillance, to mitigate potential risks posed to patients.
• Keep Accurate Records: Manufacturers should maintain detailed documentation of all surveillance activities for compliance and for responding to any inquiries by the US FDA.

The US FDA may have to take additional actions, based on the results of the PMS if the surveillance raises new issues or questions regarding the safety and efficacy of a medical device. These actions may include:

• Requesting changes to the labeling of the device to reflect additional information gathered from PMS.
• Issuing a new PMS order to address any new issues that are identified.
• Considering administrative or Regulatory actions to protect public health, such as device recall or requesting an update to a device’s indications for use statement.
• Taking compliance or enforcement actions if the data provided in the report is insufficient or raises new concerns.
• Issuing safety communications to provide recommendations on patient management, if required.

Through the above actions, the US FDA intends to ensure the continued safety and efficacy of medical devices on the market and protect public health.

To conclude, PMS and reporting are not merely Regulatory obligations, but they are also integral to the safety and efficacy of medical devices throughout their lifecycle. By adhering to the US FDA’s requirements and implementing best practices, manufacturers can contribute to the protection of public health and the advancement of medical technology. As medical devices continue to evolve, so do the strategies for monitoring their post-market performance and ensuring that patient care remains at the forefront of innovation. For all your US FDA-related medical devices requirements, connect with Freyr and let our Regulatory experts guide you through the process!