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The reorganization of CDRH’s Office of Compliance and creation of a Division of Manufacturing Quality has provided a shot in the arm to the center’s Case for Quality Initiative — fueling two pilot programs designed to increase inspection efficiencies without sacrificing quality, OC Director Steve Silverman says. Read More
Advanced Magnetic Research Institute received an FDA warning letter related to violations in three clinical studies of a magnetic molecular energizer, including failure to get IRB approval. Read More
Devicemakers that make modest improvements to their products will, in most cases, not need to file a new 510(k), the FDA says in a report released to Congress on Tuesday. Read More
House and Senate lawmakers are demanding the FDA strengthen its whistleblower protections after concluding the agency improperly spied on emails of five agency scientists in the CDRH device review division who reported product safety concerns to Congress. Read More
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