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US Postmarket Surveillance Requirements for Medical Devices

This video reviews the medical device postmarket surveillance requirements for the US FDA. On February 9th, we hosted a live webinar reviewing the EU requirements for PMS in the morning. You can view that webinar on our YouTube Channel:    • EU Postmarket Surveillance Requiremen...   In this video we reviewed 522 Orders for Postmarket Surveillance Studies and Post-approval studies for devices with humanitarian device exemptions and premarket approval (i.e., PMA). The video also reviews how to search for PMS data using specialized software from Basil Systems. Timestamps 0:00 Introduction 1:20 ISO 13485:2016, Clause 8.2.1 1:38 21 CFR 820 Requirements 2:37 What are the US FDA Postmarket Surveillance Requirements? 3:16 Two types of US FDA Postmarket Surveillance Requirements 3:54 Using the FDA Databases 4:53 Post-approval Studies (PAS) 5:50 522 Orders for Postmarket Surveillance 8:06 Links to PAS & 522 Databases 8:26 Metrics on 522 Orders 11:11 Metrics on Post-approval Studies (PAS) 14:48 Comparison of 522 vs PAS 15:41 What if the FDA required PMS? 17:56 How are you supposed to use PMS? 24:01 Why collect PMS? 25:24 FDA inspection of postmarket surveillance 29:43 Live-streaming topic for Friday February 10 31:17 Basil Systems Regulatory Module Demonstration 38:10 Basil Systems Postmarket Surveillance Module Demonstration 50:10 Review of Exported Data from PMS Module 52:40 Verification of Data Accuracy with FDA Database 53:46 Review of Comparison Table Exported 55:19 Easy Medical Device Podcast on EU vs USA PMS requirements 56:11 Contact Us Link to PAS Database - https://www.accessdata.fda.gov/script... Link to 522 Database - https://www.accessdata.fda.gov/script... Link to Easy Medical Device Podcast -    • How to do Post Marketing Surveillence...