Knowledge

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Follow us:

Publications

Hogan Lovells Publications

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on...

Analysis

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

Preparing for advisory panel meetings

Hogan Lovells Publications

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

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

FDA Updates Supporting Materials for Expedited Access Program Medical Device Alert

FDA's Expedited Access Program (EAP) provides a process aimed at increasing efficiency and smoothing the path to market for medical devices that address unmet medical needs associated with...

Hogan Lovells Publications

HHS Final Rule Expands ClinicalTrials.gov Reporting Requirements for Medical Device Studies Medical Device Alert

On September 16, 2016, the Department of Health and Human Services (HHS) issued a final rule to expand the availability of information about applicable clinical trials provided via...

Hogan Lovells Publications

FDA Draft Guidance Reaffirms Utility of Real-World Evidence in Medical Device Regulatory Decision-Making Medical Device Alert

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...

Hogan Lovells Publications

New Draft Guidance Outlines FDA’s Key Considerations for Adaptive Designs in Clinical Studies Medical Device Alert

On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the...

Hogan Lovells Publications

New Draft Guidance Outlines FDA’s Proposed Framework to Collect and Use Patient Preference Information in Device Submissions and Labeling Medical Device Alert

On May 13, 2015, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Patient Preference Information – Submission, Review in PMAs, HDE Applications, and...

Hogan Lovells Publications

New Draft Guidance Outlines FDA’s Key Considerations in Accepting Foreign Data Medical Device Alert

On April 21, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States,...

Loading data