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FDA Proposes Regulatory Framework for Artificial IntelligenceMachine Learning Software as a Medical Device

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.

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

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.

FDA Announces “Modernization” Reforms to Medical Device Review Process

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.

HHS issues proposed rule that would revise the Federal Policy for the Protection of Human Subjects

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.

FDA initiates Expedited Access Pathway program for medical devices via final guidance document

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.