Looking to make good on previous promises to foster rather than hinder innovation in the medical device industry, the FDA has released draft guidance outlining its updated pre-Investigational Device Exemption (IDE) program. According to an item announcing the guidance in the July 13 Federal Register, the updating includes giving IDE a simpler name: the Pre-Submission Program.
The new and improved pre-submission process aims to guide medical device manufacturers interested in getting early indications on the regulatory soundness of products just as, or soon after, they enter companies’ product-development pipelines.
The guidance describes the procedures agency staff will follow at the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) when industry reps and application sponsors request meetings with the agency. It also offers suggestions on meeting reviewers’ requirements for completeness in application documents.
FDA said the draft is open for comment until Oct. 11.
The announcement followed four days after President Obama signed into law the reauthorization of the Medical Device User Fee Act as part of the Food and Drug Safety and Innovation Act. Set to kick in Oct. 1, “MDUFA III” calls for industry to double the user fees it pays FDA in exchange for faster and more consistent reviews.
The announcement preceded the July 14 publication of an investigative report by the New York Times documenting the surprising scope of a previously uncovered operation by FDA officials to spy on their own scientists and review staff. The original story broke in January.