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Final guidance on a voluntary program for qualifying medical device development tools (MDDT) for the evaluation of devices regulated by CDRH has been reissued by the FDA with minor process clarifications. Read More
After analyzing four additional years of data, the FDA has decided to reverse its 2019 judgment of the mortality risk of paclitaxel-coated devices, saying data do not support a finding of excess mortality risk. Read More
Over the past week, the FDA has issued draft guidances on inborn errors of metabolism, clinical trial postmarketing studies and human cellular and gene therapy products. Read More
The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Read More
After analyzing four additional years of data, the FDA has decided to reverse its 2019 judgment of the mortality risk of paclitaxel-coated devices, saying data do not support a finding of excess mortality risk. Read More
The FDA’s recent final guidance on clinical decision support software prevents physicians from fully disclosing critical health information and therefore violates the First Amendment, a Florida law professor has written in her citizen petition to the FDA. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and a webinar from FDAnews, a WCG company on design control. Read More
Outset Medical has announced that it received a warning letter from the FDA for promoting use of its Tablo hemodialysis system for continuous renal replacement therapy (CRRT) which is outside of current indications for the device, and for a lack of clearance of TabloCart, an accessory for the system. Read More
Dubbing the Patent Trial Appeal Board’s (PTAB) rationale “doubly infected by error,” the U.S. Federal Court of Appeals gave Axonics the win as it vacated PTAB’s denial of Axonics appeal against Medtronic and remanded the case back to PTAB for reconsideration. Read More