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June 17, 2017

New FDA policies could hasten approvals of ‘lower risk’ health tech

by John_A

The FDA is making an effort to keep up with the digital world. The commissioner of the FDA said in a statement yesterday that the agency would be outlining ways to streamline the regulation of digital health devices.

Digital products are becoming a growing presence in the medical world. Examples range from simple apps, to digital pens that can predict brain conditions to systems like IBM’s Watson that can do everything from analyze medical images to devise cancer treatment plans. And the FDA wants to foster this industry by creating more efficient policies that will boost innovation rather than hinder it.

One change the agency plans to make is to bring some clarification to its policies regarding new technologies. The goal, said Commissioner Gottlieb, is to write policies that developers can easily work within without having to first consult the FDA on their position.

Secondly, for products representing a low risk to consumers, the FDA wants to make it easier for them to get on the market. To do this, the agency is considering how to create a third party certification program that, among other things, could assess a company’s history of testing and maintenance of their software designs as well as their quality. This would allow these products to hit the market without the FDA having to pre-review them first.

More details regarding this initiative are still to come, but for the developers of the estimated 165,000 health apps available to smartphone users last year, this streamlining is sure to be good news.

Source: FDA

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