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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...

David Horowitz, Janice M. Hogan, 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, Danielle C. Humphrey, Kristin Zielinski Duggan, Janice M. Hogan, Lina R. Kontos, Yarmela Pavlovic, 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USA - May 4 2018 On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and...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, Jennifer Agraz Henderson, Kristin Zielinski Duggan, Lina R. Kontos, Yarmela Pavlovic.


FDA releases working model for Software Precertification Pilot Program

USA - May 3 2018 Last week, the U.S. Food and Drug Administration (FDA or the Agency) released updates to its Software Precertification (Pre-Cert) Pilot Program...

Jodi Scott, Danielle C. Humphrey, Tammi Tram Huynh, Suzanne Levy Friedman, Lina R. Kontos, Yarmela Pavlovic.


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...

Erkang Ai, Janice M. Hogan, Lina R. Kontos, Yarmela Pavlovic.