Medical Devices
FDA Clears Meridian Congenital Cytomegalovirus Assay
FDA clears a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test.
Federal Register
Info Collection Extension for Environmental Impact Considerations
Federal Register notice: FDA submits to OMB an information collection extension entitled Environmental Impact Considerations.
Human Drugs
FDAs New Real-World Evidence Strategic Framework
FDA commissioner Scott Gottlieb announces release of a strategic framework for advancing use of real-world evidence in 2019.
Medical Devices
Medtronic Ventilator Field Correction is Class 1
FDA says a Medtronic field corrective action for its Puritan Bennett 980 ventilator series is a Class 1 recall.
In Vitro Companion Device Labeling Guidance
FDA issues a guidance on class labeling for companion diagnostic products for classes of oncology therapeutic products.
Human Drugs
Mylan Expanding Valsartan Recall
FDA says Mylan expands its recall of several types of valsartan-containing products.
Medical Devices
FDA New Approach to Regulating In Vitro Tests
FDA commissioner Scott Gottlieb and other agency leaders call for a new unified approach to regulation of in vitro clinical tests.
Medical Devices
POPS! Blood Glucose Monitoring Device
FDA clears a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system.
Human Drugs
Tris Pharma Recalls Infant Ibuprofen
Tris Pharma recalls three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the product higher concen...
Human Drugs
FDA Wants Food Handler Antiseptic Product Info
FDA opens a docket for stakeholder comments and data on the safety and effectiveness of antiseptic products intended for use in commercial or regulate...
