FDA Proposes Deregulation of Certain Class I and II Medical Devices

9-23-2013 10-03-55 PM

The Food and Drug Administration published new draft guidance last week that outlines a revised approach to premarket regulation of certain low-risk class I and II medical devices. The proposal applies to an extensive list of products that, until now, would have been required to go through the lengthy and expensive 510(k) premarket notification process.

510(k) clearance is a kind of premarket application used by the FDA to track and regulate new products being introduced into well established product categories. It is seen as the lesser of two evils by medical device manufacturers because the 510(k) route to market is cheaper and quicker than bringing a device through the full premarket approval process, which requires expensive clinical trials. Essentially, medical device manufacturers that want to market a class I or II device must submit a 510(k) premarket notification. The premarket notification process is designed to let the FDA review the device in question to ensure that it does not require full premarket approval, and to confirm that it is “substantially equivalent” to other products that are already on the market. Once this has been established by the FDA, the medical device manufacturer receives approval to market their device in the US.

The FDA clears over 3,000 medical devices a year under the  510(k) process. The process takes an average of five months from submission to approval. A 2010 Stanford University report found that the average cost of bringing a device through the 510(k) process, from submission to approval, is $24 million, a significant barrier for startups trying to bring new devices to market. The new draft guidance published by the FDA removes these barriers entirely for a number of medical device manufacturers.  The list of proposed devices that would no longer need 510(k) clearance is extensive, and includes:

  • Body Composition Analyzers – devices, typically digital scales, that use electrical current to measure impedance. Most digital scales today use impedance and weight to calculate a variety of health metrics, such as body fat percentage.
  • Digital First Aid Kits – apps or other programs designed to help non-clinical end users respond to emergency medical situations.
  • Hearing Aid and Hearing Aid Calibrators are also both being considered for declassification. Smartphone app developers have been attracted to this market in recent years, hoping to bring a easily calibrated, smartphone powered, hearing aid for patients that only need the aids occasionally.

The FDA has been striving to achieve a 90-day approval goal for the 510(k) process for some time, but has yet to reach the target. The new draft guidance could go a long way in reducing its review workload and bringing it closer to reaching that goal. Removal of the 510(k) requirement also helps health IT startups because it removes a significant barrier to entry for certain markets, making VC funding easier to secure and generally promoting more innovation in those areas. 


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