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Results: 1-10 of 11

Industry reacts to FDA proposed revisions to acceptance of data from clinical studies for medical devices

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 18 2013

On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical

FDA and FTC issue warnings for illegal homeopathic weight-loss remedies

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • December 20 2011

At the end of November, the Food and Drug Administration (FDA) issued warning letters to seven companies marketing diet products containing human chorionic gonadotropin (hCG

Issues facing foreign exporters: finding an initial distributor

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 24 2011

Companies that manufacture medical devices abroad (considered “foreign exporters” by the FDA) face a number of regulatory hurdles if they want to market their products in the U.S

FDA issues much-anticipated draft guidance on de novo classification process

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 4 2011

The FDA’s draft guidance on the de novo classification process is finally available for comment purposes

Medical device user fees: recent developments

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • August 9 2011

The July 15 meeting minutes between the FDA and industry indicate that discussions continue to focus on “mitigating uncertainties” that exist in the medical device authorization process

Medical device user fees: FDA and industry continue to debate

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 21 2011

The FDA Amendments Act (FDAAA) requires that the FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in order to develop recommendations for the next Medical Device User Fee and Modernization Act (MDUFMA) program, which will span fiscal years 2013-17

U.S. government accountability office update on FDA medical device oversight

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • April 21 2011

On April 13, 2011, the United States Government Accountability Office (GAO) testified before the Senate Special Committee on Aging regarding FDA's regulation of high-risk medical devices

FDA releases CDRH action plan for 510(k) and science initiatives

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 24 2011

On January 19, 2011, the US Food and Drug Administration (FDA) released a plan for 2011 involving 25 action steps to improve the most common regulatory-approval path for medical devices, the 510(k) process

FDA’s medical device review process: 510(k) premarket notification process scrutinized

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • November 5 2010

As many know, on August 3, 2010, the Food and Drug Administration (FDA) released proposed reforms to the 510(k) premarket notification program

FDA and CMS announce intention to collaborate in two major areas

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 6 2010

All companies within the health care industry should be aware of two recent developments in the area of medical device approval and federal health care program reimbursement