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Suzanne Levy Friedman

Hogan Lovells

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New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

USA - October 10 2018 On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k)...

Jodi Scott, Arthur E. Kim, Blake E. Wilson, John J. Smith, Yarmela Pavlovic, Kelliann H. Payne, Randy Prebula.

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, Danielle C. Humphrey, Jane Kalinina, Yetunde Oni, Meredith Manning, Susan S. Lee.

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

USA - May 11 2018 On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell...

Lowell Zeta, David Horowitz, Robert Church, Mike Druckman, Randy Prebula.

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, Danielle C. Humphrey, Tammi Tram Huynh, Lina R. Kontos, Yarmela Pavlovic.

FDA signals increasing focus on cybersecurity requirements

USA - April 25 2018 With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial...

Jodi Scott, Yarmela Pavlovic, Paul Otto.