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Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. Read More
The FDA has posted the second warning letter in two weeks for Baxter Healthcare, this one citing supplier control slips and other issues at its Irvine, Calif., manufacturing plant. Read More
Philips Respironics, a subsidiary of Philips Healthcare, has initiated a voluntary worldwide recall of about 600 Trilogy ventilators due to a potentially defective component on the power management board. Read More
There’s now a strong possibility the European Parliament won’t finalize proposed medical device and IVD regulations before elections this May, a lawyer familiar with the legislation says. Read More
The FDA’s monitoring of in-house emails of five agency whistleblowers that went public with product safety complaints was not supported by agency policy and may have violated the Fourth Amendment and the Whistleblower Protection Act, House Republicans and an HHS watchdog charged Wednesday. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More