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FDA Breakthrough Devices Program guidance targets health inequality

The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health ...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

Podcast: Talking the cure

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

Medical device 510(k) submissions must be electronic by October 2023, FDA says

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

FDA delays UDI database enforcement for low-risk devices

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

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

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

Senate proposes greater FDA oversight of Lab Developed Tests
Registered Content

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

FDA updates “cybersecurity in medical devices” guidance, seeks industry input

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...

News

COVID-19 Report for Life Sciences and Health Care Companies

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

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...

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