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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.
News
15 November 2022
The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health ...
Hogan Lovells Podcasts
24 October 2022
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...
News
23 September 2022
The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device...
News
04 August 2022
On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce...
News
21 June 2022
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug...
Insights and Analysis
Registered Content
31 May 2022
On May 17, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee published a discussion draft of their FDA user fee program reauthorization package, the “Food and...
News
15 April 2022
The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...
News
01 March 2022
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....
Insights and Analysis
01 March 2022
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...
