In September 2022, FDA Updated the Software Guidance Policy for Device Software Functions and Mobile Medical Applications.  Last revised in September 2019, the policy is intended to clarify FDA’s regulatory oversight on software functions, including those used on mobile platforms and general-purpose computing platforms as well as software in the function or control of a...Read More

On November 15, 2022, I had the pleasure to log in to a “live” FDA CDRH Industry Basics Seminar on Understanding Risk with Medical Devices.  You can view the workshop at this link: https://fda.yorkcast.com/webcast/Play/4aecf454d2d54039a1d5a6a3001d78c31d I did enjoy the materials presented and I do think the presenters Joseph and Tonya did a great job. I would recommend...Read More