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FDA Issues Draft Guidance on Pre-Submission Program to Help Device Makers Gain Early Agency Feedback

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Originally published July 12.

Expanding on its pre-investigational device exemption, or pre-IDE, program, the US Food and Drug Administration issued draft guidance this week on a new effort called the Pre-Submission Program, through which device manufacturers can seek FDA's input on an investigational device before formally applying for regulatory approval.

In launching the so-called Pre-Sub Program, the FDA is hoping to help medical device manufacturers identify the regulatory requirements they will need to meet early in the product development cycle and ahead of filing a device application such as an IDE, premarket approval, humanitarian device exemption, 510(k) premarket notification and de novo.

The Pre-Sub Program will likely be a critical point of engagement for developers of companion diagnostics that are supporting the development of personalized medicine products. Ahead of the latest draft guidance on the Pre-Sub Program, FDA officials have been urging sponsors to submit pre-IDE data to gain FDA's insights on the development program for companion diagnostics (PGx Reporter 9/22/2010).

The draft guidance defines a presumbission as a "formal written request from an applicant for feedback from FDA to be provided in the form of a formal written response or, if the manufacturer chooses, a meeting or teleconference in which the feedback is documented in meeting minutes." Device sponsors should use the Pre-Sub Program when they require the agency's feedback on questions they need answered in order to advance the development of or marketing application for a product.

A pre-submission is voluntary and not a requirement for sponsors. However, the FDA notes in the draft guidance that engaging the agency through a pre-sub might come in particularly handy when a device product uses new technologies; it's the "first of a kind" device; it’s a multiplex device that interrogates many analytes. The agency recommends pre-sub meetings might be appropriate when sponsors are developing an in vitro diagnostic involving a new technology, intended use, analyte, or clinical question; are advancing devices utilizing complex statistical methods; are developing devices for which there are unclear predicate methods. Most molecular diagnostics for personalizing treatment or medical care fall in to many of these categories.

Sponsors can also hold pre-sub meetings with the FDA to inform the agency about a particular device or clinical trial; obtain feedback on the agency's expectations for a marketing application, or ask the agency about potential problems with a specific development program.

The FDA emphasizes in the draft guidance that the Pre-Sub Program is only meant to answer sponsors' specific questions about product development. The agency informs sponsors that they should not request pre-sub meetings as a way to have general policy questions answered; request clarification of guidance documents; determine the class a device falls into; discuss the clinical data for an investigational device after a marketing application has been initiated; or appeal a regulatory decision on a product.

The agency further explains in the draft guidance that due to resource constraints, the FDA cannot prepare or design particular study plans or pre-review clinical trial data as part of a pre-sub engagement process. "However, if the data and conclusions are difficult to interpret, it may be appropriate to ask a specific question regarding the interpretation of preliminary results," the agency explained.

The draft guidance was issued July 13. The public has 90 days from this date to comment on the draft document.

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