Streamlining AE Reporting in PMCF Studies (FDA Perspective) | MedTech Voices

Device Advice by RQM+

Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies?

In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient process, allowing for the submission of a single summary report for AE data collected in PMCF studies.

🍿 You'll want to watch for...

Valuable FDA Insights: Learn about exemptions and variants for AE reporting.

Efficient Data Collection: Discover how surveying healthcare providers and analyzing anonymous patient data leads to meaningful AE data collection.

FDA Collaboration: Understand the FDA's approach to determining reporting requirements and encouraging the proactive collection of real-world data.

Streamlined Reporting Process: A single summary report could replace multiple individual reports, easing the burden on manufacturers.

From exemptions and variances to collaborative reporting efforts, this discussion between Anastassia Young, MS and Jaishankar Kutty, Ph.D. is packed with valuable information that can help your company navigate the AE reporting more effectively.

🕒 Jump to a specific segment in the video:

00:00 Introduction and Background
01:00 FDA Discussion on Adverse Event Reporting
03:05 Exemptions and Variants for Reporting
04:26 Collaboration with FDA for Reporting
05:14 Streamlining Reporting Process
06:11 Summary and Blog Announcement
07:06 FDA's Mission and Collaboration

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