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Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation
  • Beveridge & Diamond PC
  • USA
  • September 23 2016

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal

“World’s Smallest Pacemaker” Experiences Sizeable Success
  • Knobbe Martens Olson & Bear LLP
  • USA
  • September 6 2016

Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra Transcatheter Pacing System

FDA proposes important revisions to good laboratory practices regulations
  • Arnold & Porter LLP
  • August 30 2016

On August 24, 2016, the Food and Drug Administration (FDA) published a proposed rule which would amend the decades-old regulations governing good

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FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures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2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance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Food, Drug and Device Law Alert - Draft Guidance on 510(k)s: FDA Issues Guidance on When Medical Device Modifications Require a New 510(k) and on Software Changes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The FDA recently issued a draft guidance titled “Deciding When to Submit a 510(k) for a Change to an Existing Device.”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FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices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On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff

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

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