The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.:
(1) Engaged in “fraud-on-the-FDA” when obtaining...more
By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...more
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”)...more
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more
3/4/2021
/ Algorithms ,
Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Manufacturers ,
Medical Devices ,
Popular ,
Regulatory Oversight ,
Software Developers
While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more
On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely...more