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Results: 1-10 of 41

HHS issues proposed rule that would revise the Federal Policy for the Protection of Human Subjects
  • King & Spalding LLP
  • 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


FDA initiates Expedited Access Pathway program for medical devices via final guidance document
  • King & Spalding LLP
  • 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


FDA revises approach to presentation of risk information in brief summary
  • King & Spalding LLP
  • USA
  • February 10 2015

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for


HHS issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov
  • King & Spalding LLP
  • 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


FDA posts new materials on proposed Laboratory Developed Test (LDT) regulatory framework
  • King & Spalding LLP
  • USA
  • November 10 2014

On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the


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


FDA holds webinar discussing final guidance on Custom Device Exemptions
  • King & Spalding LLP
  • 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


FDA issues final Medical Device Recalls Guidance
  • King & Spalding LLP
  • USA
  • October 16 2014

On October 15, 2015, the U.S. Food and Drug Administration's Center for Devices and Radiological Health ("CDRH") issued a final guidance document


FDA’s substantial equivalence guidance
  • King & Spalding LLP
  • USA
  • September 2 2014

The U.S. Food and Drug Administration (FDA) has issued a final guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in


FDA issues 510(k)substantial equivalence draft guidance - describes benefit-risk factors considered for new 510(k) devices with different technical characteristics
  • King & Spalding LLP
  • USA
  • July 28 2014

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When