Hilary Hoffman

Morrison & Foerster LLP

+ Follow Contact

Latest Posts › Medical Devices

Share:

QMSR: Welcomed By The Industry, But Lacking In Practicality

On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more

4/4/2022 / Comment Period , FDA Approval , Federal Register , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Software , Proposed Rules

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

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

3/8/2022 / Comment Period , Federal Register , Food and Drug Administration (FDA) , Inspections , ISOs , Medical Devices , Quality Control Plan , Risk Management

FDA Inspires Modifications And Quick Authorizations For Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical...more

3/31/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies

3 Results

View per page

Page: of 1