FDA Revamps Event Reporting System with Smartphone App

4-24-2013 9-13-39 PM

The FDA announces that it will revamp its FDA Adverse Event Reporting System, which acts as a central reporting agency for clinicians in the field to report possibly dangerous flaws in high-risk medical devices like defibrillators, pacemakers, and joint implants.

Until now, the FDA has relied on mandatory reporting by companies and voluntary reporting by doctors to actively monitor the medical device market. A new early warning system will apply big data analytics to information from patient’s medical records, bills, and insurance databases. The FDA hopes to cull out patterns in device malfunctions or surgical replacements over time.

To supplement the new system, the FDA is launching a smartphone app that will streamline the reporting process for physicians, ideally encouraging doctors to report malfunctions more often.

↑ Back to top

Founding Sponsors

Platinum Sponsors