In order to sell diagnostic devices in the U.S., in vitro diagnostic (IVD) manufacturers need to get marketing authorization from FDA. That raises an obvious question: How does a company know what data to submit and which regulatory pathway to use?
One way is to ask FDA for guidance. The Office of In Vitro Diagnostics has been receptive to meeting with companies and discussing clinical study plans and proposed regulatory pathway. These meetings are accomplished through the pre-IDE (investigational device exemption) process. (The term pre-IDE is something of a misnomer, because virtually all of these meetings occur without the company submitting an IDE.)
Should IVD companies request a pre-IDE meeting? If so, when? How can they get the most out of the meeting? This article will discuss these and other questions.
For many products, there is little point in seeking a pre-IDE meeting. Many IVDs—particularly ones that will go through the 510(k) process because these are virtually identical predicate devices—will traverse a well-defined process. FDA has issued guidance documents explaining what data are needed to obtain 510(k) clearance for many different diagnostics, such as drug-metabolizing enzyme-genotyping systems. These documents provide a road map for generating data and preparing the 510(k). Even where there is no guidance document, companies may be able to follow in the footsteps of predecessors. FDA posts on its website the internal review memorandum for many IVD 510(k)s; these documents can reveal what kinds of studies the 510(k) holder submitted. Although less detailed, the 510(k) summaries of safety and effectiveness are routinely posted on FDA’s website.
Companies, however, should not blindly follow these documents. Sometimes, pertinent details are omitted. If the documents are old, they may not be reliable; FDA frequently changes its data requirements. Just as road maps can become obsolete, so can FDA’s guidance documents and product-clearance precedents. Still, for well-established products, there is little reason to incur the delay and costs of holding a pre-IDE meeting.
Many IVDs, particularly new molecular diagnostic tests, are blazing their own paths, however. There are no maps to study, and the sponsor is facing terra incognito. Companies in this position should strongly consider requesting a pre-IDE meeting, even if a 510(k) is feasible.
Premarket Approval Application
Pre-IDE meetings are especially advisable for products that will be the subject of a premarket approval application (PMA). FDA makes a summary of the safety and effectiveness data for approved PMA publicly available. These summaries provide useful insights into what tests other companies conducted. Transcripts from panel meetings can be invaluable resources. Nevertheless, given the significant investment any PMA entails, it generally would be prudent to get FDA’s feedback on the study design. Assuming that what worked a few years ago for one company will still work today could be a costly mistake.