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Danielle C. Humphrey

Hogan Lovells

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Regulatory Insights for Life Sciences and Health Care Investments: Digital health and medtech

USA - December 11 2018 Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure...

Michael S. Heyl.

FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

USA - November 28 2018 On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director...

Arthur E. Kim, Jennifer Agraz Henderson, Jonathan S. Kahan, Kristin Zielinski Duggan, Janice M. Hogan, Lina R. Kontos, Yarmela Pavlovic, Randy Prebula.

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What you should know

USA - October 19 2018 On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of...

Jodi Scott, Alex Smith, Lina R. Kontos, Yarmela Pavlovic, Randy Prebula, Paul Otto.

FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

USA - June 14 2018 On June 12 the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidance documents regarding the types of information that drug and...

Jodi Scott, Arthur E. Kim, Heidi Gertner, Jennifer Agraz Henderson, Suzanne Levy Friedman, Jane Kalinina, Yetunde Oni, Meredith Manning, Susan S. Lee.

FDA releases working model for Software Precertification Pilot Program

USA - May 3 2018 Last week, the U.S. Food and Drug Administration (FDA or the Agency) released updates to its Software Precertification (Pre-Cert) Pilot Program...

Jodi Scott, Jonathan S. Kahan, Tammi Tram Huynh, Suzanne Levy Friedman, Lina R. Kontos, Yarmela Pavlovic.