Publications

Hogan Lovells Publications

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What you should know

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

Hogan Lovells Publications

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...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

Medical device crowdfunding and preapproval promotion: Where does FDA draw the line?

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...

Hogan Lovells Publications

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

Hogan Lovells Publications

CDRH's Voluntary Malfunction Summary Reporting Program

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part...

Published Works

Three reasons attys should learn a foreign language

Attorneys who have mastered foreign languages quickly realize that their unique talent makes them stand out in their profession, and the skill is something that helps them across practice...

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