FDA's New Pre-Submission Guidance: Information is Power

By Joni Bouley and Tom Varricchione, Senior VP of Clinical & Regulatory Affairs

The FDA’s Pre-IDE (Investigational Device Exemption) program, which originally began in 1995, has recently changed its official title and scope. The program is now referred to as the Pre Submission (Pre-Sub) guidance, and has been adjusted for a broader range of subjects, including devices regulated by the Center for Biologics Evaluation and Research. The original purpose of the program was to obtain FDA feedback on future Investigational Device Exemption (IDE) applications prior to their submission, but with the program’s success and widening capacity, modifications had to be made. The FDA’s Pre-Submission program is completely voluntary, and involves creating a formal, written request. The FDA’s responses to this request can either be written, or via meeting face-to-face or online. The Pre-Sub program can benefit and streamline the product development process by serving as a checkup along the way, and can also guide future FDA application prep. Actively participating in the Pre-Sub program is beneficial to both sides, and is encouraged by the FDA for this reason.

Submitting a formal Pre-Sub program request can be done at various points throughout a product’s development, but the most opportune times are:
Pre-Submission is especially invaluable if the product incorporates novel technology or is the first of its kind in some way.

• BEFORE performing studies to develop performance data
• BEFORE submitting an IDE
• BEFORE submitting marketing applications

The Pre-Sub process is not meant to be used more than once, so it is necessary that submissions be well-prepared and thorough. Some important tips to remember when considering the Pre-Submission process:
Though the Pre-Submission program is meant to be an opportunity to improve the chances of releasing a successful product, nothing is certain. But companies should still make thorough preparations and understand all of the nuances of the program before submitting a request.

• The FDA will not prepare or design study protocols.
• They assume you will follow all of the recommendations provided in their responses.
• The Pre-Sub review does not provide a guarantee of clearance or approval of future submissions.

Ximedica’s Clinical & Regulatory Affairs team offers comprehensive insight into the world of FDA guidance; this is one of our strongest capabilities. Staying up-to-date with the ever-changing regulatory landscape is something we hold at paramount importance. For more information, contact Tom Varricchione, Senior VP of Clinical & Regulatory Affairs or David Robson, VP of Business Development.

Visit us next week for Part II of this article, which will delve into the FDA’s feedback process, as well as a list of all the things the Pre-Submission program will not do for you…