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New York Times Has Loose Understanding of How FDA Works

Today's New York Times has a somewhat critical piece on the balloon sinuplasty procedure offered by Acclarent, Inc. of Menlo Park, CA. It's a relatively new procedure with a lot of promise but some legitimate questions about its scientific value. The problem with the article, though, has to do with this passage: "The hype may be getting ahead of the science, say some leading sinus specialists, who concede that sinuplasty may hold promise.

They see the rush to embrace balloon sinuplasty as an example of how the loose regulation of medical devices can enable procedures to be adopted more on the basis of astute marketing than clinical science." "Loose regulation of medical devices?" That statement is laughable to anyone who's ever worked in industry. The Times apparently believes that the entire 510(k) process constitutes "loose regulation." Never mind that CDRH has required more clinical data from 510(k) applicants in recent years, or that it has stepped up its postmarket regulation efforts to get unsafe and ineffective devices pulled from the market. What would the Times have FDA do, then? Subject all 4,000 or so 510(k) products reviewed each year to the PMA process? How would the Times propose to pay for that? How would the Times justify the excruiatingly slow pace that new, valuable medical technologies would be introduced to the market? Seems like the author, Reed Abelson, never considered such questions. Let's hope Mr. Abelson puts more thought and less knee-jerk blather into his subsequent articles about the device industry. (In the interest of full disclosure, MD&DI has named Acclarent one of its 50 Companies to Watch, a feature which will appear in the June issue. But we would have objected to the characterization of the 510(k) process regardless of which firm's technology was being discussed.)

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