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DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
The International Medical Device Regulators forum will immediately suspend auditing organizations from the Medical Device Single Audit Program if there is evidence of any wrongdoing during a facility audit. Read More
The Centers for Medicare & Medicaid Services is mostly consistent in selecting suppliers and computing single payment amounts in the competitive bidding program for durable medical equipment (DME), but the agency needs to ensure that all bids from winning suppliers are included in the calculation of single payment amounts before offering contracts, a report recommends. Read More
A new combination product to treat opioid overdose has garnered FDA approval, in what appears to be an effort by the agency to fight charges of indifference to opioid abuse issues. Read More
Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
C.R. Bard received an FDA Form 483 for storage area control and other manufacturing issues. The company had not performed temperature mapping studies to find “cold spots, hot spots, dead spots.” Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More