After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry.

On Feb. 18, the FDA held a day-long meeting to address the 510(k) system, which it has used for more than three decades to review and clear medical devices to be sold in the United States. The 510(k) refers to the section of the Federal Food, Drug and Cosmetic Act that requires manufacturers of medical devices to notify the FDA of their intent to market a medical device at least 90 days in advance. Also known as premarket notification, the 510(k) process is intended to be applied to devices that are similar to products currently on the market.

Therein lies the crux of the issue—as ever-more sophisticated and complicated medical devices are being created, more and more “high risk” devices (those that are life-sustaining and/or implanted in the body) are slipping through the cracks and being approved under the 510(k) process, even though they may share only a trivial similarity with a device already being sold.

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