A long-running complaint from the device industry has been that the U.S. Food and Drug Administration is slow and opaque in how it reviews and communicates with companies developing new products.
On Thursday, the agency issued draft guidance on a new program that appears to show that it has taken the criticism to heart (and also comply with the user fee agreement that was recently signed into law). The guidance updates and broadens a program meant to provide earlier feedback to companies developing products.
To be called the Pre-Submissions or “Pre-Sub” program, the goal is to get companies talking to the FDA early in the product development cycle instead of waiting before they make a formal application. By communicating earlier and making FDA aware of novel technologies, companies can lower some of the regulatory uncertainty in developing an innovative device. It can also help to facilitate informal meetings between agency staff and device makers.
“No matter the regulatory pathway, FDA’s early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH), in a news release.
Broadly there are two occasions before a Pre-Sub may be submitted — before conducting a clinical, nonclinical, analytical studies, or submitting an investigational device exemption (IDE), or marketing application and/or before submitting a marketing application. But even within the two categories there are specific occasions that would call for Pre-Sub submission.
According to the draft guidance, a Pre-Sub submission would be appropriate when: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;
- the proposed indication will cause the device to be a first-of-a-kind device;
- 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 predicate of 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;
- 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;
- you desire FDA input on specific issues related to your planned clinical studies, especially if they involve complex or novel statistical approaches, and/or you desire FDA input on a clinical protocol before conducting a clinical study that does not require FDA review of an IDE, such as for a nonsignificant risk device or a study you plan to conduct entirely outside the U.S. (OUS);
- 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);
- 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).
Yet, it is important to note that the guidance is meant to be a one-time feedback and not what the FDA calls an iterative process encouraging a back-and-forth. The actual draft guidance may be read here. It also provides information on what documents are needed to submit a Pre-Sub.
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