Publications

Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...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

FDA releases working model for Software Precertification Pilot Program

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its ...

Hogan Lovells Publications

FDA signals increasing focus on cybersecurity requirements

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical...

Hogan Lovells Publications

FDA finalizes guidances for NGS-based tests

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests....

Hogan Lovells Publications

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the ...

Hogan Lovells Publications

Artificial Intelligence and your business: A guide for navigating the legal, policy, commercial, and strategic challenges ahead

Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning.

Hogan Lovells Publications

Digital Health: The issues you need to consider to leverage its full potential in 2018

Technology is changing the way the healthcare industry operates, bringing huge potential for untapped business opportunity. At the same time, with these changes comes a dramatic shift in...

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