FDA Report Card 2015

See how our panel of regulatory experts rated the agency on everything from transparency and consistency to UDI implementation.

The relationship between FDA and the medtech industry seems to have been improving in recent years, but in which areas is the agency getting better? We asked a panel of regulatory experts to grade FDA's performance in everything from transparency and consistency to implementation of the unique device identification system. The panel members were:

Here's how the regulator stacked up. 

 

 

[image courtesy of JAKER 5000/iSTOCKPHOTO.COM]

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Is a medical device "right for you?" Time for Precision Devices

It is time to adopt Precision Devices as the framework for medical and dental device regulations at FDA, and recognize that people have different tolerances vs. reactivity to device materials installed. Just as patients need to know if a prescription medication is "right for you," they need to know if a device is "right for you" before it is installed.

We are launching a bipartisan, multi-stakeholder campaign for Medical and Dental Device Safety Urgent Reform (MEDDSURGE). Please join this important effort that will improve health outcomes, and lower healthcare costs for patients, health plans, and payers, and costs for device manufacturers alike. It is win-win. Thank you.

MEDDSURGE Petition: http://www.petition2congress.com/18325/medical-dental-device-safety-urge...
Contact: https://www.linkedin.com/in/laurahenzerussell