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New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement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In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and


ACI Medical Devices Boot Camp Features New CDRH Director of Clinical Compliance Robin Newman
  • McGuireWoods LLP
  • USA
  • July 26 2016

On July 21-22, the American Conference Institute (ACI) held its Fourth Annual FDA Boot Camp: Medical Devices Edition in Chicago, Illinois. The


The federal payment Sunshine Law
  • Ropes & Gray LLP
  • USA
  • September 26 2011

On January 1, 2012, manufacturers of drugs, biologics, devices and medical supplies covered under Medicare, Medicaid and the Children’s Health Insurance Program must begin tracking payments and other transfers of value made to physicians and teaching hospitals in order to comply with federal requirements known as the federal payment sunshine law (“Sunshine Law”).


Clinical evaluation requirements for medical devices developed in the field
  • Hodgson Russ LLP
  • USA
  • March 11 2011

The February 11, 2011 FDA Warning Letter to Anelux brought the need for Investigational Device Exemption (IDE) compliance to the forefront.


FDA revises informed consent regulations to incorporate clinical trial registration requirements
  • Latham & Watkins LLP
  • USA
  • January 7 2011

On Tuesday, January 4, 2011, the U.S. Food and Drug Administration (FDA) issued a Final Rule amending the current informed consent regulations pursuant to the requirements of the Food and Drug Administration Amendments Act of 20072 (FDAAA).


A new era in FDA recall authority
  • Hodgson Russ LLP
  • USA
  • July 29 2010

On July 13, 2010, the FDA issued specific requirements for Baxter, a global medical products and services company, to use in recalling infusion pumps.


Medical Devices Directive changes
  • Fasken
  • European Union
  • March 25 2010

The European Commission has issued guidance on the implementation of Directive 200747EC ("200747") amending Directive 90385EEC and Directive 9342EEC which comes into force on 21 March 2010.


Rising regulatory and congressional scrutiny of facilities using radiation-emitting devices
  • Morgan Lewis
  • USA
  • February 5 2010

The New York Times recently published a series of articles that highlighted medical issues associated with excessive or incorrect radiation exposures in therapeutic applications.


Proposed Sunshine Act would impose additional regulation on physicians and pharmaceutical and medical device companies
  • Seyfarth Shaw LLP
  • USA
  • April 6 2009

Senators Charles Grassley and Herb Kohl have introduced the Physician Payments Sunshine Act of 2009 (the "Sunshine Act").


Massachusetts restricts marketing activities and mandates disclosures by drug and device manufacturers
  • Hogan Lovells
  • USA
  • September 4 2008

On Sunday, August 10, Massachusetts Governor Deval Patrick signed into law Senate Bill 2863: “An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care.”