We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Articles

Results 1 to 5 of 29
Most popular |Most recent


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, Lynette A. Zentgraft, Elaine Tseng, Beverly H. Lorell, MD, Jessica Ringel.

FDA issues draft guidance on medical device accessories

USA - February 3 2015 On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining...

Quynh T. Hoang, Lynette A. Zentgraft, Elaine Tseng.

HHS issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

USA - December 15 2014 On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed...

Seth H. Lundy, Elaine Tseng, Beverly H. Lorell, MD, Christina M. Markus.

D.C. Circuit rejects FDA’s claim of inherent authority to reclassify a device by rescinding a 510(k) substantial equivalence order

USA - November 6 2014 On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration ("FDA") failed to follow the appropriate...

Anne Pierson Allen, Lynette A. Zentgraft, Elaine Tseng.

FDA holds webinar discussing final guidance on Custom Device Exemptions

USA - October 27 2014 On October 14, 2014, the U.S. Food and Drug Administration (FDA or "the Agency") held a webinar for industry to explain the guidance document...

Anne Pierson Allen, Elaine Tseng, Jessica Ringel, Steven Niedelman.