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How to make 510(k)s more okay

FDA’s new plan containing 25 actions for 2011 aims to improve the most common path to market for medical devices.

iStock_PDA_med_devices
iStock_PDA_med_devices

The U.S. Food and Drug Administration announced in mid-January that it was going to embark on a large, multifaceted set of steps aimed at improving the 510(k) process for clearing new medical devices for marketing.

Nowadays, many categories of medical devices are completely exempt from having to file any kind of premarket notice or application with the FDA before entering the market. Among those that do have to file something, the vast majority file notifications under the 510(k) program, which is easy to explain and harder to practice. The easy explanation is that it involves simply a demonstration to FDA that a company’s medical device is “substantially equivalent” to a preexisting medical device that is legally on the market.

This is a process that has been amplified and improved over the years, but is still fraught with uncertainty and inconsistency for device makers and packagers. Making the process more efficient and predictable would be welcome. Packagers of new medical devices often find themselves struggling with questions about exactly whether their particular medical device is or isn’t exempt from having to file a 510(k), and if not exempt, what exactly they are required to file.

Although the conventional wisdom is that a 510(k) rarely if ever requires clinical studies (controlled experiments in people), sometimes they do, and knowing clearly in advance whether you do or don’t could make the difference between pursuing a new product or not doing so because it is too expensive.

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