Day: October 4, 2018

The list of planned Guidance Documents is a good indicator of FDA’s priorities for the coming year. Each year each center at the FDA publishes the list of Guidance Documents it plans to publish or draft next year. CDRH’s list of Guidance Documents shows that software-based products are the top priority of the Center this … Read more

Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process to include most modifications of previously approved 510k devices. The special 510k … Read more