The pre-Investigational Device Exemption ("IDE") program, established in 1995, was originally intended as a way for sponsors to obtain FDA feedback on future IDE applications.
Over time, the program expanded to include feedback on other submissions, such as premarket approval ("PMA") applications, humanitarian device exemption ("HDE") applications, and premarket notification (510(k)) submissions. To update the pre IDE program to account for its expansion, on July 13, 2012, FDA issued a draft guidance titled, “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff,” which renames the pre-IDE program the Pre-Submission ("Pre-Sub") program and also broadens the program to include devices regulated by the Center for Biologics Evaluation and Research ("CBER").
As with pre-IDEs, Pre-Subs are voluntary, and it is up to the sponsor to decide whether one is necessary. FDA encourages early interaction between it and the sponsor to “improve the quality of subsequent submissions and facilitate the development process for new devices.” The draft guidance also states that FDA will attempt to maintain continuity between various Pre-Subs related to the same topic by tracking as supplement submissions subsequent to the original submission. If the sponsor anticipates more than one Pre-Sub for the same device/ indication, FDA asks that the sponsor submit an overview of the expected submissions in the original Pre-Sub.
The draft guidance provides examples of circumstances in which FDA believes it is particularly useful to submit a Pre-Sub. For example, it may be useful when the new device involves novel technology; the proposed indication will cause the device to be a “first of a kind” device; or the sponsor desires FDA input on specific issues related to planned clinical studies.
In an appendix, FDA provides recommendations for the information that should be included in specific types of Pre-Subs (PMA, 510(k), IDE, HDE). The draft guidance also discusses informational meetings, in which FDA does not provide feedback to a sponsor, and submission issue meetings, which a sponsor can request to discuss deficiencies identified during review of a 510(k) notification, PMA, HDE, IDE, or de novo submission.
One of industry’s primary concerns about the pre-IDE program has been that FDA often provides advice and guidance in a pre-IDE meeting and then subsequently changes its position. The sponsor then must decide whether it has sufficient resources to address FDA’s newly stated concerns, or if it must abandon its efforts due to FDA’s new approach.
Though the draft guidance clearly states that advice provided in a Pre-Sub is “not decisional or binding on the agency or the applicant,” it also states that FDA intends to commit to the advice provided in a Pre-Sub, “unless the circumstances sufficiently change such that [the] advice is no longer applicable, such as when a sponsor changes the intended use of [its] device after [FDA] provide[s] feedback.”
Later, the draft guidance further limits when FDA may change the advice given in a Pre-Sub: “Modifications to FDA’s feedback will be limited to situations in which FDA concludes that the feedback given previously does not adequately address important new issues materially relevant to a determination of safety or effectiveness that have emerged since the time of the Pre-Sub.” This is not exactly an iron clad guarantee, but if FDA adheres to this approach, it will help provide greater certainty in the product review process. It is fair to say, then, that this draft guidance is a step in the right direction.