Sponsorships and Speaking Engagements

21 October 2018 | 1:30 PM - 4:15 PM (PT)

Lina Kontos is a speaker in the Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2) session at the Magi's Clinical Research Conference - 2018 West on...

Hogan Lovells Publications

19 October 2018

October is National Cybersecurity Awareness Month and the Food and Drug Administration (FDA or the agency) has been busy.

Sponsorships and Speaking Engagements

16 October 2018

On October 16, 2018, Danielle Humphrey led an Advanced Medical Technology Association (AdvaMed) workshop titled "510(k) Post-Clearance Process."

Hogan Lovells Publications

10 October 2018

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...

Published Works

October 2018

The medical device industry has long sought more comprehensive guidance from the Food and Drug Administration (FDA or the agency) regarding the line between appropriate and inappropriate...

Blog Post

05 October 2018

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...