Publications

Published Works

The FDA is innovating the approach to digital medical devices

By the time you read this article, it may well be outdated. And that's a good thing for digital health companies.

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...

Hogan Lovells Publications

New FDA final guidance on medical device panel meetings provides certain changes to timelines and procedures

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or,...

Hogan Lovells Publications

Clinical Evaluation of Medical Software: FDA Proposes International Guidance

On October 14, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document addressing clinical evaluation for standalone software. The draft guidance,...

Hogan Lovells Publications

Highly Anticipated FDA Draft Guidance Documents on 510(k) Device Modifications Add New Considerations to the Decision-Making Process for Companies

On August 8, 2016, FDA issued two highly anticipated draft guidance documents, entitled Deciding When to Submit a 510(k) for a Change to an Existing Device1 (general guidance) and Deciding ...

Hogan Lovells Publications

FDA Draft Guidance Reaffirms Utility of Real-World Evidence in Medical Device Regulatory Decision-Making

As part of a series of efforts1 by the U.S. Food and Drug Administration (FDA) to "think outside the box" when it comes to the evidence required to support regulatory decision-making, on...

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