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Amgen could not certify to an FDA inspector that it had evaluated a contractor that serviced its equipment, according to a recent warning letter. Read More
Baxter Healthcare landed an FDA warning letter that includes multiple repeat observations and issues related to test methods, CAPAs and over-infusion with its elastomeric infusion systems. Read More
A recent decision by the Centers for Medicare & Medicaid Services to give devicemakers extra time to submit detailed reports under the Physician Payment Sunshine Act could lead to complacency, an industry attorney warns. Read More
Devicemakers should take steps now to secure a production account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More
The timeline for a bipartisan agreement to repeal the Medicare sustainable growth rate formula is a little less uncertain as it failed to make it into the debt ceiling bill passed Tuesday. Read More
CDRH plans to reduce the number of IDEs requiring more than two cycles to make a determination by 25 percent by Sept. 30, and by 50 percent by June 30, 2015. The aim is to get the median time for full IDE approvals down to 30 days by June 30, 2015. Read More
Industry hopes that new Russian device regulations would speed up the pace of registrations and approvals have paled as regulators struggle to create implementing guidance. Read More
The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says. Read More