Tag: FDA

FDA Will Regulate Some Apps As Medical Devices

In an important move, the U.S. Food And Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on devices like the iPhone and Android mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices.* The statement is the final word from the FDA on the approach it will take when enforcing federal regulations regarding the safety of medical devices to the large and fast-growing category of medical applications. The agency said on Monday that, while it doesn’t see the need to vet “the majority of mobile apps,” because they pose “minimal risk to consumers,” it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed “using the same […]

FDA: Medical Device Makers, Hospitals Need To Boost Cyber Security

The U.S. Food and Drug Administration (FDA) has issued guidance to medical device makers and hospitals that use their products to pay more attention to cyber security and the potential for cyber attacks on vulnerable medical instruments.   The FDA released its “Safety Communication for Cybersecurity for Medical Devices and Hospital Networks” on Thursday – the same day that the Department of Homeland Security’s ICS (Industrial Control System) CERT issued a warning about the discovery of hard coded “back door” passwords in some 300 medical devices from 40 separate vendors, including drug infusion pumps, ventilators and patient monitoring systems. The FDA said it expects device makers to “review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices or compromise of the security of the hospital network that may be connected to the device. Hospitals were instructed to harden […]