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The FDA’s process for bringing devices to market starts with a device’s risk classification and moves next to the level of controls placed on the device — not only for approval purposes but also for manufacturing, labeling, packaging and other activities that are monitored throughout a product’s lifecycle for enforcement purposes.
Texas-based Dalton Medical, a manufacturer of powered wheelchairs, adjustable hospital beds and other durable medical equipment, received a Form 483 for failure to establish design control and complaint handling procedures, among other lapses.
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.
It can help to learn more about an FDA inspection team ahead of time, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
The FDA handed cardiac device manufacturer Atrium Medical a Form 483 after a July-August 2022 inspection of its facility in Merrimack, N.H., found inadequate design and process controls among other lapses described as repeated systemic deficiencies.
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.