Michael Heyl

May 30, 2024 | jdsupra.com | Michael Heyl |Randy Prebula |Jodi Scott

May 30, 2024 Michael Heyl, Randy Prebula, Jodi Scott Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing.” Although the final version of the guidance mostly resembles the draft guidance, FDA...

May 29, 2024 | lexology.com | Jodi Scott |Michael Heyl |Randy Prebula

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing.” Although the final version of the guidance mostly resembles the draft guidance, FDA adds detailed examples and analyses of the regulatory requirements and considerations for “remanufacturers,” emphasizing their obligations to comply with agency rules relating to...

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.