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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

News

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...

News

FDA updates FAQ on COVID-19 tests and validation

Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions...

Media Mention

Hogan Lovells helps Nets owner donate ventilators to hospitals Law360

Hogan Lovells represented the Joe and Clara Tsai Foundation in meeting the U.S. Food and Drug Administration's requirements to import ventilators and personal protective equipment and then...

News

SweynTooth cybersecurity vulnerabilities: considerations for medical device manufacturers

The U.S. Food and Drug Administration (FDA) announced a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks...

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,...

Analysis

FDA proposes process for receiving nonbinding feedback on establishment responses to Form 483s
Registered Content

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device...

News

MDR single report exemption and ASRs: Coming to an end for most reporters

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and...

News

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process[1]. Although De Novo review has been...

News

Continued FDA emphasis on use of real-world evidence in active postmarket device surveillance

On 20 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren released a joint statement...

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