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Results: 1-10 of 134

New French Sunshine Act guidance

  • Hodgson Russ LLP
  • -
  • France, USA
  • -
  • July 11 2013

On June 12, 2013, the French Ministry of Health published Circulaire No. DGSPF22013224 relative to Article 2 of the Law No. 2011-2012 of December

Decree on advertising medical devices in France

  • Hodgson Russ LLP
  • -
  • France
  • -
  • August 27 2012

A new French law wants to strengthen the safety of drugs and medical products

Final rules: essential health benefits, cost-sharing, and actuarial value

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • May 31 2013

Beginning in 2014, non-grandfathered individual health insurance policies and policies issued to small employers must provide "essential health

FDA regulation of medical devices: hot topics and recent news

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 9 2012

Here are a few recent topics of interest to the medical device industry:

The application of the medical device excise tax to foreign manufacturers selling to end-users in the United States

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • May 6 2013

As of January 1, 2013, the first sale of a taxable medical device in the United States by a manufacturer, producer, or importer has been subject to a

Proposed regulations issued for excepted benefits

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • February 28 2014

The Departments of the Treasury, Labor, and Health and Human Services recently issued proposed regulations that generally expand the definition of

Medical device importers still required to submit device malfunction reports

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • March 11 2011

In a notice dated Tuesday, March 8, 2011 (PDF), the FDA purports to clarify the requirements for reporting device malfunctions by device importers

FDA's final rule for combination products

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 29 2013

On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable

Departments issue wellness program final regulations

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 31 2013

The Departments of Health and Human Services, Labor, and Treasury issued final wellness program regulations. These final rules are applicable to

The Trade Adjustment Assistance Extension Act extends Health Coverage Tax Credit

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

On October 11, 2011, the Trade Adjustment Assistance Extension Act was signed into law