Publications

Hogan Lovells Publications

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on ...

Hogan Lovells Publications

Indonesia to relax foreign investment rules

As part of its 16th economic package, the Government of Indonesia (GOI) announced on 16 November 2018 that in order to attract further foreign investment, it intends to relax the...

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New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will...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

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