Publications

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...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to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the ...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

What device companies need to know ahead of an advisory panel meeting

Preparing for advisory panel meetings
For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or...

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

UK M&A: Brexit and investment in UK life sciences

While Brexit is likely to result in sweeping changes to the UK’s life sciences sector, the rate of M&A and foreign investment is a positive sign that the region will uphold its...

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