U.S. law allows whistleblowers to file suit for violations the False Claims Act, but the legality of these qui tam relators under the Appointments Clause is under intense scrutiny thanks to a case heard in Florida district court.
Three former officials with Magellan Diagnostics Inc., have entered guilty pleas in connection with faulty tests for lead poisoning that were widely used across the U.S. between 2013 and 2017. While former CEO Amy Winslow and two others will not be sentenced until later this year, all three face possible prison terms of three years or more and fines of as much as $250,000, highlighting the hazards of a lack of scruples with regard to compliance with U.S. FDA regulations.
The latest continuing resolution (CR) for the U.S. budget funds government operations through the end of the fiscal year, which in modern times may come across as an achievement. However, Medicare telehealth also won in the CR, which extends some temporary measures for telehealth as Congress continues to mull over the question of a permanent expansion of Medicare telehealth benefits.
The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.
The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain.
The U.S. FDA’s latest draft guidance on pulse oximeters drew comment from the International Standards Organization and the International Electrotechnical Commission, which are making the case that in addition to differences in pigmentation, the pulsatility of the tissue in contact with the device is also a factor in device performance.
Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
The widespread need for cartilage repair may have bred optimism on the part of Spinalcyte LLC when it filed a related patent in 2014, but the Patent Trial and Appeal Board has affirmed a rejection of the patent due to lack of enablement, an object lesson regarding the need for clarity in patent applications.
The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.
The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.
