FDA Feedback: New Guidance For Device Applicants

Law360, New York (August 6, 2012, 1:19 PM EDT) -- On July 13, 2012, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued a highly anticipated draft guidance document intended to eventually supersede the March 25, 1999, "Blue Book Memorandum Pre-IDE Program: Issues and Answers."

While the pre-IDE process was originally developed for sponsors to obtain feedback on future investigational device exemption (IDE) applications, over time, these meetings evolved to allow for feedback on other types of device applications, such as premarket...
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