Hogan Lovells Publications

CDRH issues final rule on appeals, excluding De Novos from 517A

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...

Hogan Lovells Publications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward...

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 Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the Data Bank."

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

Hogan Lovells Publications

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...

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