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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.
On the website GoodRx, a two-pack of Viatris’ branded EpiPen can cost more than $635, while a generic version costs anywhere from $100 to more than $280.
The German-based certification organization DEKRA has temporarily suspended the CE certificates for Getinge’s HLS and PLS life support sets effective March 1 due to noncompliance with the EU’s Medical Device Directive.
The FDA explains the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirement for a new 510(k) filing, in a final guidance released yesterday — one of six newly released guidances from the agency related to imaging solutions and lasers.
The U.S. Supreme Court has refused to review a $302 million judgment levied against Johnson & Johnson (J&J) by California for misrepresenting the risk of its pelvic mesh products in marketing materials.