Publications

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

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

FDA Updates Supporting Materials for Expedited Access Program

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

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FDA Draft Guidance Reaffirms Utility of Real-World Evidence in Medical Device Regulatory Decision-Making

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New Draft Guidance Outlines FDA’s Key Considerations for Adaptive Designs in Clinical Studies

On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the...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New Draft Guidance Outlines FDA’s Proposed Framework to Collect and Use Patient Preference Information in Device Submissions and Labeling

On May 13, 2015, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Patient Preference Information – Submission, Review in PMAs, HDE Applications, and...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New Draft Guidance Outlines FDA’s Key Considerations in Accepting Foreign Data

On April 21, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States,...

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