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Top Democrats express concern on FDA’s effort to relax regulations on digital health apps, other software

The FDA is working on a plan to make it easier for companies like Apple and Fitbit to sell medical software like smartphone apps. At least three top Democrats are…
Source: Justin Sullivan/Getty Images

WASHINGTON — The top ranking Democrat on the Senate health committee has “a number of concerns” with how the Food and Drug Administration might regulate medical software such as smartphone apps.

“It is essential that changes to FDA’s regulatory framework are done in compliance with the current statutory framework and do not compromise public safety,” the to the FDA Wednesday.

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