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New Draft Guidance Designed to Improve Pre-Submission Process

Thursday, July 12, 2012  
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The FDA issued draft guidance this week designed to formalize and improve the pre-submission process for medical device innovators. The new program, called "Pre-Sub," is designed after a similar program for drugmakers where regulators and industry meet and agree on specific designs and goals for clinical studies in an effort to improve the regulatory pathway.

"FDA's early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process," said Christy Foreman, director of the Office of Device Evaluation in CDRH.

To view a copy of the draft guidance, click here.