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

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

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Publications

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),...

News

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...

News

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...

News

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.

News

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.

News

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign...

Hogan Lovells Publications

Our FDA Medical Device and Technology compliance team receives ISO 13485 auditor certification Medical Device and Technology Alert

Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world,...

News

FDA moves to formalize processes and standards via draft guidance on routine inspections

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment...

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