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Today, the FDA released the final guidance document “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” This guidance provides labeling and safety testing recommendations for medical devices that contain heparin.  The guidance is intended to help reduce heparin product overdose errors caused by misinterpretation of the expression of drug strength in product labeling.

The FDA Issues Final Guidance - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics.

Today, the U.S. Food and Drug Administration (FDA) released the final guidance document, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics.”  The recommendations in this guidance are intended to promote consistency, predictability, and transparency in the device submission review process when determining substantial equivalence for devices with different technological characteristics.

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