U.S. Food and Drug Administration - News, Features, and Slideshows

News

• Many wearable devices won't require FDA regulation

  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.

• FDA approves tech that turns smartphone into stroke warning system

  The FDA today approved an algorithm that allows a special iPhone case to record the heart's rhythm and detect abnormalities associated with strokes or other heart-related problems.

• US FDA to regulate only medical apps that could be risky if malfunctioning

  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.

• US regulator shuts down 1,677 Internet pharmacies

  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.

• US FDA calls on medical device makers to focus on cybersecurity

  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.

• House to meet on regulating mobile health apps

  A House committee this week is meeting to determine whether regulations, including a possible tax on mobile health apps may stifle innovation in healthcare.