Originally established in 1995, the pre-IDE program provided applicants with a mechanism to obtain FDA feedback prior to their submission. Since 1995, the program grew to provide feedback on Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (de novo petitions), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs).
To address the broad scope of the program, FDA decided to change the name from the pre-IDE program to the Pre-Submission (Pre-Sub) program. In addition to introducing the Pre-Sub program, the guidance also describes what information to include in a Pre-Sub package in order to get the best feedback; the guidance also addresses other types of FDA feedback currently available.
This guidance will likely help streamline sponsors’ pre-sub interactions with FDA and provide industry with guidance on how to prepare high-quality pre-subs. After issuing draft guidance in July 2012, FDA received several comments regarding the administrative process and policies of the Pre-Sub program. The newly released final guidance serves to address these issues by providing an overview of the mechanisms available to request feedback from FDA before a planned submission. An acceptance checklist now exists to explain how FDA determines whether a submission includes sufficient information for FDA to provide feedback. FDA also received comments regarding the timeframes for FDA’s feedback to the applicant; the current FDA target for providing feedback is 75 days following a Pre-Sub, and generally takes no longer than 90 days.
FDA will use this guidance to inform regulatory decisions regarding the Pre-Sub program and meetings with FDA staff. The guidance should also encourage industry to seek early advice from FDA on complex regulatory issues likely affecting FDA’s review processes and timeframes. Comments on the final guidance may be submitted at any time.
View the full FDA guidance here.