Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Follow us:


Insights and Analysis

FDA proposes to conform the Quality System Regulation to the ISO 13485 standard

On February 22, the U.S. Food and Drug Administration (FDA) published its long awaited proposed rule entitled, “Medical Devices; Quality System Regulation Amendments,” which...


“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when...


FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting...

Hogan Lovells Publications

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on...

Hogan Lovells Publications

We can help you prepare remotely for your next Quality Management System inspection or audit

The global spread of COVID-19 has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of the U.S. Food and Drug Administration (FDA),...


FDA temporarily postpones all domestic routine facility inspections in response to COVID-19 pandemic

On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic...


FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus...


Revised ISO 14971 Application of Risk Management to Medical Devices released

ISO 14971:2019 Medical devices – Application of risk management to medical devices is a new update on the 2013 version of this global standard.


FDA delays draft rule for QSR/ISO 13485 harmonization Medical Device Alert

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020.

Loading data