Tariffs applied to goods imported for China were imposed by the Trump administration as part of a larger effort to reset the U.S. trade deficit, but there were several exclusions for medical devices in the interest of maintaining access.
The U.S. FDA has at last published what is nominally a draft rule for harmonization of the Quality System Regulation (QSR) with an international standard, ISO 13485, but the draft rule is conspicuous for the absence of specifics.
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
The Biden administration has posted a request for information (RFI) about the conditions necessary for the in vitro diagnostic industry to sustain testing capacity for communicable disease outbreaks, although the letter commits to no specific actions. The Advanced Medical Technology Association responded to the RFI with the recommendation that the administration quickly commit to the provision of resources as a means of ensuring that “market volatility will no longer determine test availability.”
The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.
Most of the better-known targets of prosecution under the U.S. False Claims Act (FCA) are drug and device manufacturers, but the Department of Justice (DOJ) seems to have opened a new front in the war on Medicare fraud.
The selection of Robert Califf to run the U.S. FDA might seem like a safe move on the part of the White House, but some believe his prior experience at the FDA does not necessarily suggest an acceptance of the regulatory status quo. Peter Pitts, president of the Center for Medicine in the Public Interest, told BioWorld that while Califf is “not a flashy pick,” Califf possesses a very keen understanding of the need to modernize the FDA’s practice of regulatory science, which should be a welcome bit of news for makers of drugs and devices.
The U.S. CMS has expanded the population of Medicare beneficiaries who are eligible for lung cancer screening via low-dose CT (LDCT) imaging. The news drew raves from stakeholders who also lauded the expansion of the facilities that can conduct the procedure, constituting a set of changes that advocates say will save thousands of additional lives.
The U.S. Senate narrowly voted 50-46 to confirm Robert Califf as the next commissioner of the FDA, a critical outcome for an agency that has lacked a fully anointed commissioner for a year. Califf, who was previously FDA commissioner under President Barack Obama from February 2016 to January 2017, faces several challenges in the coming year, however, including the agency’s accelerated approval program for prescription drugs, which has added drag to the process of registering him as the new commissioner.
The U.K. National Institute of Health and Care Excellence has endorsed the use of stereotactic radiosurgery as a treatment of trigeminal neuralgia (TN) after hearing from a patient group, promising more clinical bandwidth for these systems.
