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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, Jennifer Agraz Henderson, Jonathan S. Kahan, Danielle C. Humphrey, Kristin Zielinski Duggan, Janice M. Hogan, Lina R. Kontos, Randy Prebula.

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling

USA - November 26 2018 On November 20, the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital...

Sally Gu, Susan S. Lee.

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, Danielle C. Humphrey, Lina R. Kontos, Randy Prebula, Paul Otto.

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

USA - October 10 2018 On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k)...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, Suzanne Levy Friedman, John J. Smith, Kelliann H. Payne, Randy Prebula.

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

USA - June 15 2018 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...

Erkang Ai, John J. Smith, Kelliann H. Payne.