FDA offers draft guidance for device ‘pre-sub’ program
The Food and Drug Administration issued draft guidance aimed at helping medical device companies address regulatory requirements before they submit an application. The agency said the draft guidance builds on its existing pre-investigational device exemption program and will provide researchers and manufacturers with feedback prior to submission of a product or research application. “No matter 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,” Christy Foreman, director of the device evaluation office in FDA’s Center for Devices and Radiological Health, said in a news release. The new program will be called the pre-submission, or “pre-sub,” program. It will operate within the investigational device exemption, premarket approval, humanitarian device exemption, premarket notification and de novo regulatory pathways. The device industry has complained about slow review times. However, earlier this year, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told members of Congress that one way for the agency to improve review times would be better submissions from manufacturers.