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The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of breakthrough...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On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices.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...
July 16, 2021
The U.S. Federal Trade Commission has undertaken several decisive moves since the beginning of the year, including the formation in March of a multi-lateral work group for mergers in the...
July 8, 2021
The United States Court of Appeals for the Ninth Circuit has set forth a key ruling in Dan Abrams Co. v. Medtronic Inc.; reasserting an important precedent for off-label use and creating a wrinkle in...
July 7, 2021
The Centers for Medicare & Medicaid Services has suspended the Medicare Coverage of Innovative Technology (MCIT) program through at least the end of the year, and possibly permanently. However, there...
