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Publications

Analysis

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

12 April 2018

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

20 September 2017

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

03 October 2016

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

26 September 2016

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FDA Draft Guidance Reaffirms Utility of Real-World Evidence in Medical Device Regulatory Decision-Making Medical Device Alert

03 August 2016

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New Draft Guidance Outlines FDA’s Proposed Framework to Collect and Use Patient Preference Information in Device Submissions and Labeling Medical Device Alert

22 May 2015

On May 13, 2015, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Patient Preference Information – Submission, Review in PMAs, HDE Applications, and...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New Draft Guidance Outlines FDA’s Key Considerations for Adaptive Designs in Clinical Studies Medical Device Alert

22 May 2015

On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the...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New Draft Guidance Outlines FDA’s Key Considerations in Accepting Foreign Data Medical Device Alert

24 April 2015

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,...

Hogan Lovells Publications

New FDA draft guidance on medical device panel meetings generally confirms current practices, provides additional detail Medical Device Alert

10 April 2015

On April 1, 2015 the Food and Drug Administration (FDA) released a draft guidance document discussing procedures for Medical Device Advisory Committee meetings, excluding the Medical...

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