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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, Kristin Zielinski Duggan, John J. Smith, Yarmela Pavlovic.


Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

USA - December 27 2018 The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for...

Jonathan S. Kahan, David Horowitz, Philip Katz, Randy Prebula.


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, Lina R. Kontos, Yarmela Pavlovic, Randy Prebula.


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, Jennifer Agraz Henderson, David M. Fox, Lina R. Kontos, Randy Prebula.


FDA's Software Pre-Cert Program: More Details Revealed

USA - August 9 2017 In follow up to the U.S. Food and Drug Administration's (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot...

Jonathan S. Kahan, Erkang Ai, Lina R. Kontos, Yarmela Pavlovic.