The Food and Drug Administration (FDA) oversees the safety and effectiveness of medical devices on the market, establishing post-market surveillance (PMS) requirements for manufacturers and distributors. These regulations are designed to monitor device performance post-approval. Post-market surveillance involves adverse event reporting, medical device reporting, corrective actions, and product performance monitoring.
Post-marketing reports are crucial for monitoring the safety and effectiveness of medical devices after they have been approved and marketed. These reports provide valuable data that can help regulatory authorities, healthcare providers, and manufacturers identify and address any potential issues or risks associated with the use of medical devices. In this blog, we will explore six key steps when completing post-marketing surveillance reports for medical devices, including which devices are applicable.
Which Medical Devices Require Post-Marketing Reports?
PMS Requirements in the U.S.: While 21 CFR Part 820 and ISO9001 govern quality system regulations for medical device firms, don't specifically address PMS. However, manufacturers in the U.S. are still required to conduct such studies. The FDA's 522 Post-Market Surveillance Studies Program, managed by the Office of Surveillance and Biometrics, ensures manufacturers conduct these studies efficiently.
The FDA can enforce post-market surveillance for class II and class III medical devices meeting specific criteria:
Likely severe negative health effects from device malfunction
Device intended to stay in the body for over a year
Likely significant pediatric use
Designed as a life-supporting or life-sustaining tool outside a medical context
The FDA can require post-market surveillance for adverse events, insufficient pre-market testing, and acquiring more data on device performance in clinical settings.
PMS Strategy Submission: In response to an FDA request, manufacturers must submit a PMS strategy that addresses the original justification for the order. A typical post-market surveillance report includes:
Device details, regulatory background, description, and intended purposes
PMS plan objectives and goals
Patient group details, inclusion/exclusion standards
Sample size calculation
Objectives, standards for success, potential negative outcomes
Follow-up schedules, evaluation methods
Information gathering forms, data assembly methods
Timelines for reports and data analyses
Post-Market Surveillance in the EU: Under Regulation (EU) 2017/745, manufacturers must include a PMS strategy in their technical documents, executed to generate PMS reports or PSU reports based on device classification.
Class I devices submit Post Market Surveillance Reports (PMSRs) under MDR
Class A and B devices submit PMSRs under IVDR
Periodic Safety Update Reports (PSURs) are mandatory for class IIa, IIb, and III devices (MDR) and class C and D in-vitro devices (IVDR), including benefits and risks, discoveries, sales figures, and user characteristics.
Key Steps to Completing a Post-Marketing Report:
Step 1: Identify the Reporting Requirements
Before starting the report, it is essential to understand the reporting requirements specified by the regulatory authority in the country where the device is marketed. These requirements may vary depending on the type of device and the regulatory framework in place.
Step 2: Collect Relevant Data
Gather all relevant data related to the device, including adverse events, complaints, and any other information that may be required for the report. This data may come from clinical studies, post-market surveillance, or other sources.
Step 3: Analyze the Data
Analyze the data to identify any trends or patterns that may indicate potential safety issues or areas for improvement. This analysis should be thorough and objective, taking into account all available information.
Step 4: Prepare the Report
Based on the analysis, prepare the post-marketing report according to the format and requirements specified by the regulatory authority. Include a summary of the data, an assessment of the device's safety and effectiveness, and any actions taken or planned in response to the findings.
Step 5: Submit the Report
Submit the report to the regulatory authority within the specified timeframe. Be sure to include all required documentation and ensure that the report is complete and accurate.
Step 6: Follow-Up
After submitting the report, be prepared to follow up with the regulatory authority if additional information or clarification is required. It is important to be responsive and cooperative throughout the process.
Conclusion
In conclusion, completing post-marketing surveillance reports for medical devices is essential for ensuring patient safety, monitoring device performance, and supporting regulatory oversight. By analyzing and acting on the information provided in these reports, manufacturers can improve the quality and effectiveness of their devices, ultimately benefiting patients and healthcare providers worldwide.
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