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Latest From Elizabeth Orr
A controversial change that could have broadened the definition of "intended use" to include almost anything discussed in manufacturer communications has been delayed indefinitely as FDA reopens the comment period.
The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.
US DoJ collected more than $1bn in penalties from device manufacturers this year, chiefly on false claims and manufacturing violations. Here is a roundup and sortable table of the payouts.
Michael Gluk, who participated in a scheme to falsely inflate ArthroCare’s earnings by parking unsold merchandise with distributors, pleaded guilty to one count of conspiracy to commit wire and securities fraud after his initial conviction was overturned.
Improper reprocessing may pose a risk of air embolism due to a leaky valve, FDA said in the recall announcement.
Baxter International has been sued by state and county governments in Illinois over allegations that the company dumped wastewater containing more than the legal limit of contaminants into a local lake. The firm says remediation efforts are underway.