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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

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The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...

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

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

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...

News

FDA explains when medical device makers must notify of an interruption in manufacturing

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...

News

COVID-19 Report for Life Sciences and Health Care Companies (Jan - Feb 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.

News

FDA transition plan for COVID-19 medical devices requests new submissions to agency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules...

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