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Medical Devices › ISOs

Foley Hoag LLP

In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

Foley Hoag LLP on

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

Arnall Golden Gregory LLP on

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

MoFo Life Sciences

Quality Management System Regulation (QMSR) – Harmonizing The Quality System Regulation (QSR) With ISO 13485:2016

MoFo Life Sciences on

The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820)...more

Mintz - Health Care Viewpoints

Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing

Mintz - Health Care Viewpoints on

On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from...more

Mintz - Health Care Viewpoints

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

Mintz - Health Care Viewpoints on

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

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