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:
[ Ссылка ]
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 - [ Ссылка ]
Link to 522 Database - [ Ссылка ]
Link to Easy Medical Device Podcast - [ Ссылка ]
