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The FDA updated its Sept. 8, 2022, safety communication to report on 19 published cases of squamous cell carcinoma (SCC) skin cancer and various lymphomas in the capsule that forms around breast implants, three of which were reported to result in patient deaths.
The FDA says more testing and analysis is needed to determine the risk of exposure to toxic compounds from tubing used in any hemodialysis or peritoneal dialysis system that has parts made of chlorinated peroxide cured silicone.
The FDA is requiring that labeling for all food allergen skin diagnostic tests be updated to contain a warning of false negative results and potential life-threatening anaphylaxis from subsequent allergen exposure.
The FDA has enrolled four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, which is designed to give faster, more widespread access to medical devices of public health importance and strengthen the agency’s Breakthrough Devices program.
The FDA’s latest updates to its Electronic Medical Device Reporting (eMDR) system will go live on March 17, making five changes to the online system devicemakers and importers must use to submit MDRs.
The association is urging lawmakers to enact the bipartisan Verifying Accurate Leading-edge IVCT Development Act (VALID) which would require the FDA to regulate in vitro clinical tests.
AdvaMed has issued a medical device agenda for the 118th Congress, laying out multiple Congressional actions to “help usher in a new era of innovation.”
The FDA said it had received medical device reports of early SVD with the Trifecta valves, which show a peak time to SVD of three to four years after implant.
Abbott has issued an advisory to customers warning of potential early structural valve deterioration (SVD) of its Trifecta Valve and Trifecta Valve with Glide Technology (GT) bovine heart valves, occurring five years or less after being implanted.