During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
The European Council applied its seal of approval to a proposal to extend the deadlines for the Medical Device Regulation (MDR), providing industry some critical breathing room to obtain certification for devices brought to market under the legacy Medical Device Directive (MDD).
The U.S. Supreme Court has declined to grant cert for a petition filed by Johnson & Johnson on behalf of its Ethicon subsidiary to review a case in California that will cost the company more than $300 million. The outcome highlights the differential hazards of advertising and promotion in various U.S. states, with California state law allowing fines of up to $2,500 for each violation of state law, an amount that can quickly tally into the hundreds of millions.
The U.S. FDA’s 2018 program for voluntary malfunction summary reporting (VMSR) was intended to ease the burden for both industry and the agency regarding low-risk malfunctions associated with a limited set of device types. However, a new draft guidance on the subject drew criticism from two trade associations for being administratively cumbersome, suggesting the guidance will need considerable cleaning up before presentation in final form.
The U.S. Federal Trade Commission (FTC) has once again waded into the question of whether medical devices should be included in the agency’s right-to-repair discussion, most recently in an advanced notice of proposed rulemaking ostensibly titled for energy labeling. The Medical Imaging & Technology Alliance (MITA) pushed back on the proposal by pointing to the draft’s required disclosure of proprietary information about a medical device system, a provision MITA said might detract from patient safety.
Med tech firms are becoming quite familiar with the world of digital health in recent years, but this has often been a pairing of strange bedfellows at best up to now. A new report by Accenture on industry adoption of digital health lays out some of the reasons for that, but some impediments come from government, such as the lag in development of regulatory policies for artificial intelligence (AI) and software as a medical device (SaMD).
The U.S. CMS has finalized the physician fee rule for calendar year 2023, a document that imposes an across-the-board pay cut of approximately 4.5% for physician Medicare services. However, the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) blasted the final rule’s failure to provide what they believe are appropriate rates for cardiac ablation services, a position backed by two med-tech trade associations in their comments to the docket for the draft rule.
The U.S. FDA recently released its guidance agenda for fiscal 2023, a plan that de-emphasizes the oft-promised draft guidance for change control for artificial intelligence (AI) algorithms, which is listed as a B priority instead of an A draft guidance priority. At this year’s Medtech Conference here in Boston, the FDA’s Melissa Torres disavowed the notion that any national regulatory authority is delaying another authority’s policy on software change control, but she acknowledged that these conversations about regulatory harmonization typically predate formal policy development.
