Hogan Lovells Publications

14 July 2020

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

12 April 2018

Preparing for advisory panel meetings

Hogan Lovells Publications

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

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

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

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

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On May 18, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Adaptive Designs for Medical Device Clinical Studies, discussing considerations related to the...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

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On May 13, 2015, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Patient Preference Information – Submission, Review in PMAs, HDE Applications, and...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

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On April 21, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States,...