FDA released a draft guidance July 12 on its evolving program for providing feedback to device sponsors prior to a company making a pre-market submission.

The draft guidelines, focusing on the agency’s pre-submission device program, dubbed Pre-Sub, are a step by FDA toward fulfilling one of its commitments under the reauthorized device user fee program, enacted last week. Specifically, the agency agreed to establish a more structured process for pre-submission meetings with industry.

The draft guidance details information that companies should include in pre-submission packages to the agency, and timeframes for scheduling meetings related to clinical studies and pre-market submissions.

The guidelines are intended to expand on the 1995-established pre-investigational device exemption (IDE) program to more clearly reflect the fact that all pre-market device submissions, rather than just IDEs, can be the subject of pre-submission meetings and to broaden the scope of the program to include devices regulated by FDA’s biologics review center.

Improving the pre-submission program was an important goal for industry during the latest round of user fee negotiations with FDA, which completed earlier this year. At one point, industry and FDA discussed specific performance goals and pre-submission user fees to fund the review of what FDA estimated to be 2,000 pre-submission requests per year. (See Also see "FDA, Industry Haggle Over Price For New User Fee Deal" - Medtech Insight, 16 January, 2012..)

FDA encourages firms to engage in the pre-submission program to obtain agency feedback prior to the submission of clinical protocols or future marketing applications.

However, in the final agreement, there was no provision for a pre-submission fee and no specified performance goals. FDA and industry agreed to a more structured, improved process for pre-submissions, but only as resources permit. (See Also see "Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees" - Medtech Insight, 6 February, 2012..)

In the draft guidance, FDA says that pre-submission meetings for IDEs and pre-market applications are “strongly encouraged.”

But the agency underscores that the program is not meant to be an iterative process, but instead intended to provide one-time advice on a particular topic. The draft guidance also stresses that information FDA provides during pre-submission meetings is not considered binding. Further, FDA notes that its review of study protocols and plans in a pre-submission meeting does not guarantee approval or clearance of future submissions.

Pre-Submission Program Parameters

The guidance attempts to outline the distinct parameters of what the pre-submission program is, and is not, meant to address. The program has been effective in the past at answering specific protocol development and test planning questions related to clinical, non-clinical or analytical studies, IDEs and marketing applications, FDA notes.

However, pre-submission meetings are not an alternative to other review processes and procedures, nor should they should be confused with other forms of informal FDA feedback, the guidance states. FDA says the program is also not a substitute for a company conducting its own research and analysis of current medical device development practices.

FDA can provide pre-submission feedback at an in-person meeting, or via teleconference, fax or email. Three days prior to a scheduled meeting or teleconference, FDA will offer initial feedback to the applicant by email, including responses to the applicant’s questions and FDA’s suggestions for additional topics to be discussed at a meeting. If all of the sponsor’s questions are addressed in FDA’s email, then FDA and the applicant can agree that a meeting is not necessary.

Included in all pre-submission requests should be a cover letter describing the reason for the request, device description, proposed intended use/indications for use, previous discussions or submissions, an overview of product development, specific questions and the preferred mechanism for feedback.

FDA will determine within 14 calendar days of receiving the request whether it meets the pre-submission definition. If it does, FDA will aim to schedule such a meeting within 75 days, and no longer than 90 days, of receipt of the request.

The guidance also details the process for documenting meeting minutes. The applicant is responsible for developing draft minutes of the information discussed in the meeting, including agreements on issues and any action items.

Within 15 calendar days of the meeting or teleconference, the applicant has to provide the draft minutes to FDA via email. Then, FDA would provide any edits to the minutes over email within 30 days. The minutes will become final 15 days after the receipt of FDA’s edits. If there is disagreement about the FDA-edited minutes, the applicant and FDA can set up a follow-up teleconference.

Other Meetings Addressed

In addition to pre-submission meetings, the draft guidance introduces two additional meeting types.

One type, called submission-issue meetings, actually would occur after a sponsor submits a clinical study or marketing application and following an initial review by the agency to discuss deficiencies identified by FDA. The meeting may pertain to a 510(k), PMA, de novo petition, IDE or humanitarian device exemption.

In submission-issue meetings, FDA says it can clarify questions that reviewers have raised with an application; however, the agency will not, in this context, pre-review a company’s planned responses to those questions. FDA plans to schedule a submission-issue meeting within 21 days of receipt of a request from a sponsor.

FDA also discusses in the draft guidance so-called informational meetings, intended to provide an opportunity for an applicant to share information with FDA without expecting feedback. For instance, a company might provide an overview of a device’s development when there are multiple submissions expected in the next 6-12 months, or to familiarize FDA with a new device. FDA says it plans to schedule a informational meeting within 90 days of receipt for the request.

Written or electronic comments on the draft guidance are due Oct. 11.

FDA Addresses Pre-Submission Meetings In Draft Guidance

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