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FDA Releases Revised Guidance on Device Modification Policy
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • August 16 2016

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the


FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures
  • McDermott Will & Emery
  • USA
  • August 15 2016

On August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance


Food, Drug and Device Law - FDA Finalizes Guidance on General Wellness Devices, Will Not Regulate
  • Barnes & Thornburg LLP
  • USA
  • August 12 2016

The FDA recently issued a final guidance titled "General Wellness: Policy for Low Risk Devices." The guidance sets forth FDA's compliance policy for


Food, Drug and Device Law Alert - Draft Guidance on 510(k)s: FDA Issues Guidance on When Medical Device Modifications Require a New 510(k) and on Software Changes
  • Barnes & Thornburg LLP
  • USA
  • August 11 2016

The FDA recently issued a draft guidance titled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” At the same time, the FDA


FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices
  • McDermott Will & Emery
  • USA
  • August 10 2016

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff


New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement
  • Cozen O'Connor
  • USA
  • August 8 2016

In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and


3D Printing: Health Care Miracle, Product Liability Nightmare, or Both?
  • Nutter McClennen & Fish LLP
  • USA
  • August 8 2016

3D printing has the potential to dramatically change the way health care is delivered. The U.S. Food and Drug Administration (FDA) has already


“Institutional Review Board (IRB) Written Procedures” Draft Guidance and NIH’s “Single IRB Policy” Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research
  • Hogan Lovells
  • USA
  • August 8 2016

Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and


FDA Issues Final General Wellness Product Guidance
  • Hogan Lovells
  • USA
  • August 4 2016

On July 29, 2016, the Food and Drug Administration (FDA or the Agency) released its final guidance document entitled, General Wellness: Policy for


FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels
  • Cozen O'Connor
  • USA
  • August 4 2016

The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms