FDA’s Pre-Submission Program

FDA’s Pre-Submission (Pre-Sub) Program allows for sponsors to meet with FDA to get feedback on medical device submissions (e.g., IDEs, PMAs, HDEs, and 510(k)s). The main purpose of the program is to provide the sponsor with a mechanism to obtain feedback from FDA prior to an IDE or marketing application, allowing a sponsor to understand the path from device concept to market. Questions that can be answered include specific questions related to product development, proposed clinical study protocols, or data requirements for submissions.

According to the FDA Guidance Document, Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff, Pre-Subs can be useful in the following circumstances:

  • “Before conducting clinical, nonclinical, or analytical studies, or submitting an IDE, IND, or marketing application when:
    • the new device involves novel technology and it may be helpful to familiarize the FDA review team with the technology in advance of the submission;
    • you are proposing a “first of a kind” indication or a new indication for an existing device;
    • the new device does not clearly fall within an established regulatory pathway, and you desire informal input on a proposed regulatory strategy;
    • the new device is a multiplex device capable of simultaneously testing a large number of analytes;
    • the new device is an in vitro diagnostic (IVD) device that contains a new technology, a new intended use, a new analyte, new clinical questions, complex data/statistical questions, and/or where the predicate19 of or the reference method is unclear or uncertain;
    • you desire FDA guidance on specific issues related to nonclinical study protocols and/or animal study protocols, before initiating your studies; or FDA input on your proposed testing is especially encouraged for studies that will have a long duration or for which there is no single clearly established consensus method for collecting the data, such as when there is no recognized consensus standard or are multiple standards from which to choose;
    • you desire FDA input on specific issues related to your planned clinical studies, especially if they involve complex or novel statistical approaches;
    • you desire FDA input on the extent that existing data may be leveraged in preparing a PMA submission for your device in accordance with section 520(h)(4) of the FD&C Act; and/or;
    • you desire FDA input on a clinical protocol before conducting a clinical study that does not require FDA review of an IDE or IND, such as for a nonsignificant risk device or a study you plan to conduct entirely outside the US (OUS).
  • Before submitting a marketing application:
    • to apprise the FDA review team on the particulars of the device and clinical study (if there have been changes since initiation of the IDE or IND);
    • to obtain feedback on the use of data collected from an OUS study to support clearance or approval;
    • to obtain our feedback on preferred data presentation and to ensure clarity with respect to our expectations regarding the elements to be included in the marketing application; and/or
    • to gain insight into potential hurdles for approval or clearance (e.g., numerous protocol deviations, missing data, or a failed study endpoint), some of which could require additional data or analyses.

Pre-Subs can be a useful way of clearing up any ambiguity associated with bringing a product to market; however, they should not be used to replace the use of guidance associated with a medical device. To learn more about Pre-Subs, read FDA’s guidance here: Requests for Feedback on Medical Device Submissions:  The Pre-Submission Program and Meetings with Food and Drug Administration Staff. If you have questions or believe you could benefit from a Pre-Sub, feel free to contact one of our knowledgeable consultants at the KAS Group.

Posted by Spencer Kimber