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MDR single report exemption and ASRs: Coming to an end for most reporters

USA - January 14 2019 The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical...

Michael S. Heyl, Edward C. Wilson, Jr., Wil Henderson, Dennis C. Gucciardo.


FDA releases final guidance document on PMA manufacturing site change supplements

USA - December 20 2018 On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the...

Michael S. Heyl, Edward C. Wilson, Jr., Dennis C. Gucciardo.


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...

Arthur E. Kim, Wil Henderson.


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...

Alex Smith, Danielle C. Humphrey, Lina R. Kontos, Yarmela Pavlovic, 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New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

USA - October 10 2018 On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k)...

Arthur E. Kim, Blake E. Wilson, Suzanne Levy Friedman, John J. Smith, Yarmela Pavlovic, Kelliann H. Payne, Randy Prebula.