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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: White House names pick for CMS administrator’s post; FDA posts advisory for pulse oximetry; CDC: Telehealth visits dropped over last half of 2020; CRS says user fee shares of total review costs on the rise; Federal Circuit kicks case back to PTAB.
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup.
Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, again criticized the U.S. FDA for taking a conventional regulatory approach to rapid antigen tests for the pandemic. However, not everyone at the FDA’s parent department deserves brickbats. Mina said Assistant Secretary for Health Brett Giroir deserves a lot of credit for assisting in the effort to stand up pilot studies for rapid antigen tests that could be used to restore the U.S. economy even in the absence of a fully rolled-out vaccination campaign.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA delays comment period for electromagnetic compatibility draft; CMS, ONC post info sharing, prior authorization rule; Van Hollen debuts diagnostic accuracy bill; CDC updates POC testing guidelines; GAO: Specimen biopsy handling errors relatively low.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts list of essential devices, drugs; Members of Congress query NIH’s Collins on RADx program; Imminent malware threat reported; CDC posts telehealth report; CMS unveils seven AI competition finalists.
