USA - April 9 2019
On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and...
Lisa M. Dwyer, D. Kyle Sampson, Krishna Kavi, Beverly H. Lorell, MD.
USA - January 22 2019
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification...
Lisa M. Dwyer, D. Kyle Sampson, Brady K Mickelsen.
USA - December 3 2018
Last week FDA released two statements announcing plans and proposals aimed at modernizing the process for medical device review, particularly the...
Quynh T. Hoang, Kathryn B Armstrong (Kate), Beverly H. Lorell, MD, Jessica Ringel, Nikki Reeves.
USA - September 28 2015
On September 8, 2015, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies collectively issued in the...
Seth H. Lundy, Beverly H. Lorell, MD, Christina M. Markus.
USA - May 11 2015
The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical...
Quynh T. Hoang, Pamela F. Forrest, Lynette A. Zentgraft, Beverly H. Lorell, MD, Jessica Ringel.