We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Results 1 to 5 of 9
Most popular |Most recent


FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance

USA - November 29 2018 On 20 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director...

Jodi Scott, Wil Henderson.


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...

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


New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

USA - October 10 2018 On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k)...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, Blake E. Wilson, Suzanne Levy Friedman, 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, Heidi Gertner, Jennifer Agraz Henderson, Danielle C. Humphrey, Suzanne Levy Friedman, Jane Kalinina, Yetunde Oni, Meredith Manning, Susan S. Lee.


FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement Decisions

USA - January 23 2017 On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding...

Michael S. Heyl, Danielle C. Humphrey.