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Jennifer Agraz Henderson

Hogan Lovells

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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, Jonathan S. Kahan, Danielle C. Humphrey, Kristin Zielinski Duggan, Janice M. Hogan, Lina R. Kontos, Yarmela Pavlovic, 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, Danielle C. Humphrey, Suzanne Levy Friedman, Jane Kalinina, Yetunde Oni, Meredith Manning, Susan S. Lee.

FDA proposes streamlining combination product regulations

USA - May 30 2018 On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR...

Heidi Gertner, David M. Fox, Janice M. Hogan, Lina R. Kontos, Randy Prebula.

Parsing products: FDA regulatory policy for multi-function medical devices

USA - May 4 2018 On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and...

Jodi Scott, Jonathan S. Kahan, Kristin Zielinski Duggan, Lina R. Kontos, Yarmela Pavlovic.

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) pathway for certain devices

USA - April 19 2018 Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft...

Danielle C. Humphrey, Michael Kasser, John J. Smith, Yarmela Pavlovic.