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Adverse Event Reporting? FDA Has An App for That

CDRH Director Jeffrey Shuren told attendees at the annual meeting of the Medical Device Manufacturers Association that FDA is building a new adverse event reporting database that will even have an app.

It’s out with the old and in with the new at the FDA.

In a speech at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C., Tuesday, Dr. Jeffrey Shuren, Director of CDRH, said that the agency is building a new database to report adverse events and it will even have a mobile app. The agecny hopes to launch the app sometime this year.

 

“The app will push through adverse events into the database that will replace MAUDE,” Shuren said, in an interview after the speech. “It would make it easier for aggregating adverse event reporting.”

The MAUDE (Manufacturer and User Facility Device Experience) database is an ancient system not particularly known for being user friendly, especially for the average person.

“If you go to the Natural History Museum, you will see a display of MAUDE there," Shuren joked.

"Maude is old. It sounds like someone's grandmother," Venture Capitalist Ross Jaffe of Versant Ventures chimed in.

Shuren may have been joking about MAUDE, but he was all business when explaining to MDMA attendees that CDRH’s review program has “turned a corner.”

He shared several slides that showed that the FDA is performing better when it comes to managing the review process that includes reducing the backlog of pending applications in both PMAs and 510(ks) that has gone down for the first time in years; the number of letters requesting additional information in the first cycle of an application is also trending lower after years of increase; and the average time to a final decision regarding approval or rejection is leveling off and maybe tipping lower after years of climbing steadily.

“The medical device program has a long way to go, but we have turned a corner,” Shuren told the audience.

Attendees, however, were less convinced. While appreciating Shuren’s presence at the conference, one by one they got up to communicate only one thing – that the changes at the top is not filtering down to the reviewer or branch level.

 -- By Arundhati Parmar, Senior Editor, MD+DI

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