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Decipher the device reference

This article was originally published in The Gray Sheet

Executive Summary

CDRH Office of Science & Engineering Laboratories Director Larry Kessler stresses the difficulty in substituting premarket requirements with postmarket conditions to speed approval decisions. At a recent Drug Information Association meeting, he recounted: "Recently we had a company approve a really high-profile product, and as one of the conditions of approval of that product, we said we need you to start a registry of new patients so we can see if some of the issues that came up in clinical trials premarket are understood in postmarket, and we're looking forward to it. Several months after the company marketed the product and had sold many, many thousands [of products]...a couple of adverse events showed up that we didn't understand. So we called the company, and we said, 'Hey, we're getting pressure. Clinicians are worried about this. We're worried about this. What have you got on the registry so we can help figure out whether this is a real safety problem?' And you know what they said? 'Registry? Oh, that was a condition of approval. We should have started that. Darn. We've sold thousands of the product, and you know, we haven't registered one person'"...

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