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Would you like an extra application with that? FDA mulls requiring dual applications for combination products

USA - February 8 2019 On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level...

Heidi Gertner, Yarmela Pavlovic, 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, Janice M. Hogan, Yarmela Pavlovic, Randy Prebula.


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, Yarmela Pavlovic, Randy Prebula, Paul Otto.


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, Janice M. Hogan, 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USA - May 4 2018 On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and...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, Jonathan S. Kahan, Kristin Zielinski Duggan, Yarmela Pavlovic.