FDA issued a draft list of Class II Medical Devices exemptions from the 510(k) premarket notification requirements to comply with the 21st Century Cures Act. Note that 884.1630 is NOT exempt if it contains software for image analysis or smartphone use. Other software-related sections of note are 86.2570 and 882.1470.Read More
Upcoming Public Courses
No public courses are planned at this time.
If you would like to discuss a private, onsite course, please fill out the form below.
