Best Practices for Using Open FDA Data in Medical Device Cases

What you'll learn

Using FDA data in medical device cases

Accessing public data for device information

Understanding FDA's device classification system

Interpreting adverse event reports effectively

Navigating Open FDA for adverse events

Identifying issues from FDA inspection reports

Webinar Details

FDA public data on medical devices is free to search but can be difficult to interpret on your own. This webinar provides an overview of medical device manufacturer registrations and adverse event reporting. We will use real examples of hip implants and the da Vinci Surgical System and learn how to find manufacturing locations, product brand names, FDA regulations for devices and adverse event data. You can use this webinar to help you search public data to decide on the merits of a potential case and if needed, retain expert consultants and witnesses.

This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.

Who is this for:

Plaintiff attorneys

Trial teams

Medical device experts

Plaintiff attorneys in FDA cases

Regulatory affairs specialists

Engineers in medical devices

Content

Introduction and Webinar Overview

3 Min

Expert Background and Perspective

4 Min

FDA Regulation of Medical Devices

5 Min

Stakeholders in Device Outcomes

4 Min

High-Risk Devices in Litigation

5 Min

Using OpenFDA Data

6 Min

Adverse Event Reporting Systems

6 Min

Product Codes and Device Identification

5 Min

Recalls, Inspections, and Form 483s

483 Min

Warning Letters and Compliance Risks

5 Min

Limits of FDA Data Interpretation

3 Min

Audience Q&A

7 Min