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center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions.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The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of breakthrough...
September 9, 2021
Anyone who has obtained a patent can attest that it is an expensive endeavor. The United States Patent and Trademark Office (USPTO) requires a fee for nearly every step taken by the applicant. These...
September 9, 2021
Device makers should be aware of the new FDA intended use rule, which concludes an overhaul of the previous version that was six years in the making. One of the key differences between the new rule...
August 16, 2021
On May 27, 2021, the FDA issued two draft guidances for studies of devices after approval or clearance. The draft guidances would impose much shorter timelines for both post-approval studies and...
August 10, 2021
On May 20, 2021, the FDA’s Center for Radiological Health (CDRH) issued a paper discussing labeling long-term medical devices to include all materials that will come in contact with human tissue. The...
July 30, 2021
On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices. With this guidance, the FDA aims to distinguish between remanufacturing and servicing and to instruct the...
July 20, 2021
There are several important differences between FDA regulations of pharmaceuticals and medical devices. These differences span from regulation of promotion and advertising to the testing requirements...