A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel.
The EU has moved aggressively on legislation in recent years, with the AI Liability Directive serving as the latest example of legislation that sparked widespread opposition.
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts. However, the report added that the total dollar value of these cases is in line with historical norms, suggesting that the average recovery amount has tapered off significantly.
While the U.S. Supreme Court sidelined itself over patent issues such as subject matter eligibility, the diagnostic patent wars are still in full swing as a casual review of cases at the U.S. Patent and Trademark Office discloses.
Australia’s Therapeutic Goods Administration posted a draft guidance dealing with non-mandatory audits for premarket applications, which says that a transcatheter aortic valve replacement device that has been approved by the U.S. FDA may not be subject to such an audit.
False Claims Act litigation in the U.S. spiked significantly according to a new report by Gibson, Dunn & Crutcher, LLP, at least in terms of the number of cases brought to the courts.
Litigation against companies in the life sciences has far too often covered those who were not injured by the device or drug, but there are signs that this tide is shifting.
The U.K.’s new postmarket monitoring requirements do not represent a sea change in device makers’ responsibilities in this area, but the expansions of responsibility are nonetheless significant.
Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.
