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Neuropsychiatric interpretive EEG assessment aids should undergo clinical performance testing to demonstrate the accuracy, precision and reproducibility of results, including any specified cutoffs, the FDA says. Read More
FDA’s continued progress under MDUFA is allowing AdvaMed to shift some of its focus from the pace of premarket reviews and approvals to the Center for Medicare & Medicaid Services’ methods for making coverage decisions on new technologies, association officials said Tuesday. Read More
Devicemakers planning a PMA or product development protocol should take advantage of presubmission determination meetings with the FDA to pin down exactly what data the agency expects to support safety and efficacy of a new product. 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
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