Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st...more
The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more
The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more
The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that...more