On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."

This Guidance updates the pre-Investigational Device Exemption (pre-IDE) program, formalizing the program's evolution, and retitling it the Pre-Submission (Pre-Sub) program. When the IDE-program was established in 1995, it was intended to provide a mechanism for IDE applicants to obtain agency feedback before the submission of an IDE. Over time, the program broadened to allow for agency feedback on clinical trials and other device submissions and the new Pre-Sub program reflects this wider scope, allowing for feedback on:

  • IDEs
  • Premarket Notification (510(k)) Submissions
  • Premarket Approval (PMA) applications, and
  • Humanitarian Device 136 Exemption (HDE) applications.

The program's Draft Guidance provides extensive direction on when meetings are appropriate, how to request a meeting, the contents of Pre-Sub packages, and guidelines for the meeting itself.

To obtain a Pre-Sub meeting, applicants must submit a written request for feedback. The feedback sought may, at the applicant's choice, be provided:

  • in a formal written response,
  • through an in-person meeting, or
  • by phone.

The Guidance outlines the requirements for Pre-Sub packages, which includes what information must be provided about the device, indications for use, and product development.

The Guidance includes examples of when it is appropriate and not appropriate to submit a Pre-Sub meeting request. Pre-Sub meetings are not a substitute for informational meetings, in which a sponsor wishes to share information with the agency, without an expectation of feedback, and submission issues meetings to address deficiencies in a submission. On the flip-side, for example, a Pre-Sub is appropriate if the device involves a novel technology and the applicant would like to familiarize the FDA team with the technology prior to the submission. As we have seen with our own clients, a Pre-Sub can be especially useful to gain insight into potential hurdles for approval or clearance.

A Pre-Sub is a very valuable tool that many applicants can use to save time and resources along the path to market. Although more than one Pre-Sub is permitted, FDA requests that Pre-Subs do not readdress already covered information. The guidance provided by the agency in the Pre-Subs is not intended to change, unless new issues arise that are materially significant to the safety or effectiveness of the device. Therefore, applicants must use the Pre-Sub tool carefully – efforts must be taken to prepare comprehensive Pre-Sub packages and to appropriately structure Pre-Sub meetings to maximize the value of agency feedback.

FDA is accepting comments on the Draft Guidance until October 11, 2012 (Docket No. FDA-2012-D-0530).

The Draft Guidance can be found here