New Initiative to Speed Medical Device Research

On the heels of their plan to accelerate the drug approval process, the FDA has also embarked on an initiative to help companies better design and develop their devices to increase their chances for approval.  The FDA’s Center for Devices and Radiological Health (“CDRH”) is teaming up with Medial Device Innovation Consortium, a public-private group created by Minnesota trade group LifeScience Alley. This group will bring together leaders from government, not-for-profits and industry to gather input and help fund projects to advance medical device research. Jeffrey Shuren, head of CDRH, says the benefits of this collaboration are safer medical device candidates and the avoidance of time and cost delays historically incurred by the industry associated with the FDA’s reapplication process.

Jaime Gilmore is an Audit Director performing audit services as well as SEC compliance, revenue recognition, equity based compensation and other complex equity instruments.

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