FDA Unveils New Rules To Speed Up Medical Device Studies

Law360, New York (November 10, 2011, 6:12 PM EST) -- The U.S. Food and Drug Administration rolled out new guidelines Thursday aimed at speeding up the development of investigational medical devices by cutting back on previous restrictions on device studies.

The new guidelines are the latest in a series of efforts the FDA and Congress have undertaken in recent months to improve the development and review process for medical devices.

The FDA says the guidelines, currently in draft form, will help stimulate innovation and promote early-stage development in the U.S., ultimately delivering important medical devices to...
To view the full article, register now.