Pre-Submission Process for IVDs.
A Pre-Submission includes a formal written request from a submitter for feedback from the FDA which is provided in the form of a formal written response or, if the submitter chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission meeting is a meeting or teleconference in which the FDA provides its substantive feedback on the Pre-Submission.
A Pre-Submission is appropriate when the FDA’s feedback on specific questions is necessary to guide product development and/or application preparation.
The FDA encourages use of a Pre-Submission under circumstances such as the following:
- The device involves new technology, a new intended use, or a new analyte and it will be helpful to familiarize the FDA with the novel features in advance of the submission;
- Assistance is needed in defining possible regulatory pathways;
- The studies involve complex data and/or statistical approaches;
- The predicate or reference method is unclear or uncertain; or
- The new device is a multiplex device capable of simultaneously testing a large number of analytes.
A sponsor should submit a Pre-Submission if they would like the FDA’s thoughts on their studies or proposals prior to starting their studies. The potential benefits of submitting a Pre-Submission are:
- to begin a dialogue with the FDA and promote greater understanding.
- to reduce the cost of research studies by focusing in on the important information needed for the FDA’s approval (or clearance) and eliminating unnecessary or burdensome studies, and
- to facilitate the review process for the future marketing application since the FDA will already be familiar with the device.
Pre-Submissions and associated meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the manufacturer or the FDA.