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The FDA's new Digital Health Plan

August 22, 2017

Thompson Coburn describes what's known so far about the FDA's Digital Health Plan in this July article published by Digital Health Legal. READ MORE

FDA’s Health Software PreCert Program to fast-track innovation

August 11, 2017

The FDA has created the Software Precertification Pilot Program to accelerate and streamline the regulatory approval process for new, disruptive, and innovative products. READ MORE

Privacy and the Internet of Medical Things: What’s a curmudgeon to do?

Matt Hafter April 12, 2017

The proliferation of Internet-connected and controlled medical devices opens up bundle of cybersecurity risks and concerns. What stance has the FDA taken so far an where is it headed? READ MORE

FDA-regulated industries: Plan now for these changes in 2016

January 28, 2016

Big changes are in store for the industries of animal health, drug, medical devices and tobacco. Among these, the FDA is expected to continue its scrutiny of animal food safety, ramp up its work in post-approval drug studies and keep a close watch on the evolution of mobile medical devices and e-cigarettes. READ MORE

FDA Update: New guidance released on mobile medical devices, medical devices data systems

August 19, 2015

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the medical industry as a potential source of revenue. READ MORE

FDA launches medical device database: AccessGUDID

May 26, 2015

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July of 2012. READ MORE