Many of the wearable devices and mobile health apps available to consumers won't be subject to U.S. Food and Drug Administration regulation, according to draft guidelines from the agency.
The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient's safety if they do not function as intended.
More than 1,600 websites selling pharmaceutical products, including some spoofing CVS and Walgreens pharmacies, were shut down this week in a sting involving 99 countries, the U.S. Food and Drug Administration said Thursday.
Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won't approve their devices for use, the FDA said.
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