Lina R. Kontos

Feb 7, 2024 | jdsupra.com | Wil Henderson |Michael Heyl |Lina R. Kontos

FDA has just published a 101-page rule titled “Medical Devices; Quality System Regulation Amendments,” finalizing the February 2022 proposed rule of the same name. It aims to harmonize FDA quality regulations, first developed in 1996, with the 2016 version of ISO (International Organization for Standardization) 13485, which will be incorporated by reference in the QMSR.

Feb 6, 2024 | lexology.com | Michael Heyl |Lina R. Kontos |Jodi Scott |Wil Henderson

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical devices.

Oct 24, 2023 | law360.com | Lina R. Kontos |Kristin Zielinski Duggan |Kelliann H. Payne

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Oct 4, 2023 | jdsupra.com | Lina R. Kontos |Randy Prebula |Jodi Scott

FDA’s new final guidance replaces the April 2022 draft guidance of the same name, which we analyzed online here, and it also supersedes FDA’s 2014 final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” There were more than 1,800 public comments on the draft version of the guidance, which FDA was required to finalize by the end of September, 2023.

Oct 3, 2023 | lexology.com | Jodi Scott |Lina R. Kontos |Randy Prebula |Alex Smith

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on how to tighten cybersecurity measures in response to rapidly evolving online threats to both patients and hospitals.