Hogan Lovells Publications

13 August 2019

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."

Hogan Lovells Publications

25 July 2019

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or...

Hogan Lovells Publications

09 July 2019

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two...

Blog Post

19 June 2019

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is...

Hogan Lovells Publications

04 June 2019

Government seeks industry comment on expediting medical product development

Hogan Lovells Publications

29 May 2019

Opinion highlights importance of a "clear" record at FDA