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Kristin Zielinski Duggan

Hogan Lovells

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In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

USA - January 24 2019 Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments...

Danielle C. Humphrey, Janice M. Hogan, John J. Smith, Yarmela Pavlovic.

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, Danielle C. Humphrey, Janice M. Hogan, Lina R. Kontos, Yarmela Pavlovic, Randy Prebula.

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

USA - September 11 2018 Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market...

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USA - May 4 2018 On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and...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, Jennifer Agraz Henderson, Jonathan S. Kahan, Lina R. Kontos, Yarmela Pavlovic.

What device companies need to know ahead of an advisory panel meeting

USA - April 12 2018 For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or...

Gerard J. Prud'homme.