Hogan Lovells Publications

CDRH's Voluntary Malfunction Summary Reporting Program

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part...

Published Works

Three reasons attys should learn a foreign language

Attorneys who have mastered foreign languages quickly realize that their unique talent makes them stand out in their profession, and the skill is something that helps them across practice...

Published Works

Wearable Medical Devices Raise Issues for Physicians

Counsel Stephanie Carman authored an article titled: "Wearable Medical Devices Raise Issues for Physicians" for the South Florida Legal Guide

Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

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