We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 134

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


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


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 Physician Payment Sunshine Act: reporting obligations and achieving compliance
  • Hodgson Russ LLP
  • USA
  • April 17 2012

Many device and drug manufacturers may not be aware of the upcoming requirements to collect data on payments made to physicians or teaching hospitals in 2012 and report them to the Centers for Medicare and Medicaid Services (CMS) in 2013


FDA issues much-anticipated draft guidance on de novo classification process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The FDA’s draft guidance on the de novo classification process is finally available for comment purposes


NYS Legislature establishes state Justice Center for the Protection of People With Special Needs
  • Hodgson Russ LLP
  • USA
  • August 26 2013

The Justice Center for the Protection of People With Special Needs opened on June 30, 2013. The center, established by the Protection of People with


MEWA held to be not fully insured under ERISA
  • Hodgson Russ LLP
  • USA
  • April 15 2011

When unrelated employers join together in an association or other group to purchase or arrange for health insurance, the association is defined as a "multiple employer welfare arrangement" or "MEWA" under the law


Teleradiology ghost reading could present False Claims Act issues
  • Hodgson Russ LLP
  • USA
  • July 11 2011

Teleradiology is becoming more and more common


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


Is PPACA constitutional?
  • Hodgson Russ LLP
  • USA
  • August 30 2011

On August 12, 2011, in State of Florida v. United States Department of Health and Human Services, the Court of Appeals for the Eleventh Circuit held that the provision in the Patient Protection and Affordable Care Act (PPACA) that requires individuals to buy health insurance or pay a tax penalty (the so-called “individual mandate”) is unconstitutional