The U.S. Food and Drug Administration issued draft guidance Friday that would in effect exempt many apps and mHealth devices from FDA oversight.
Under the guidance, certain Class I and Class II devices that are seen by a FDA as lower risk would not have to undergo the FDA's 510(k) review process before being marketed and sold. These low-risk devices include personal digital health products such as talking first aid kits and exercise devices, and apps that turn smartphones into a stethoscope or other monitoring device. The 60-day comment period means a final rule is months away, though the FDA said it would not regulate these devices in the interim, essentially putting the rule into effect now.
The guidance is good news for mHealth. Developers will be able to bring many products to market more quickly, reducing the financial strain of waiting for FDA approval and encouraging more developers to enter the space.
"This is big news, and a huge boost to the mHealth industry," Bradley Merrill Thompson, counsel to the mHealth Regulatory Coalition, told Politico. "It shows that FDA is being extremely practical in reviewing its own practices, and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources."
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