Life Sciences News and Resources
Featured Resources
October 27, 2021
Attendees to this webinar will learn more about the following: What is Human Factors/Usability Engineering (HF/UE) for medical products? What are the regulatory bodies asking for around HF/UE? How...
October 15, 2021
In September 2021, FDA’s Digital Health Center of Excellence released a list of artificial intelligence/machine learning-based software as a medical device (“AI/ML-based SaMD”) that are marketed...
October 14, 2021
The FDA’s device center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions. While the updates are...
October 5, 2021
On July 7, 2021, FDA released their final guidance document regarding the content and forms of Unique Device Identifiers (UDIs). The recommendations are written specifically for labelers of medical...
September 22, 2021
The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of breakthrough...
