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Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 7
  • Jones Day
  • USA
  • September 21 2016

On November 9 and 10, 2016, FDA will host a public hearing to obtain feedback on the Agency's regulation of communications by manufacturers, packers

Proposed rule would allow Medicare Advantage plans to limit patient choice of medical devices
  • McGuireWoods LLP
  • USA
  • November 7 2011

On October 11, 2011, the Centers for Medicare and Medicaid Services (CMS) proposed changes to Medicare Part C regulations that would enable Medicare Advantage (MA) plans to limit access to Medicare-covered items, including limiting coverage to specific items and brands of durable medical equipment (DME) supplies.

Medical product companies ask FDA to clarify policies on off-label uses
  • Shook Hardy & Bacon LLP
  • USA
  • July 14 2011

Leading U.S. pharmaceutical and medical device manufacturers have filed a citizen petition with the Food and Drug Administration (FDA) calling on the agency to clarify its regulations and policies on off-label uses of drugs and medical devices.

Commission consults on EU transparency rules in relation to pricing and reimbursement of medicines
  • Matheson
  • European Union, Ireland
  • May 2 2011

European Member States are responsible for their own health insurance schemes and for determining the pricing for medicines and their reimbursement status.

Proposed radio license seeks to advance wireless medical device innovation
  • Foley & Lardner LLP
  • USA
  • March 24 2011

The FCC has proposed a new experimental radio license that is intended to facilitate development of wireless medical devices.

FCC seeks to grant broader experimental licenses; targets medical applications and new radio technologies
  • Womble Bond Dickinson (US) LLP
  • USA
  • December 20 2010

Seeking to foster research and innovation in wireless technologies, the Federal Communications Commission has proposed new rules designed to broaden spectrum research and the development of spectrum-efficient wireless technologies.

Implanted neuromuscular stimulator notice comments dates released
  • Reed Smith LLP
  • USA
  • May 15 2009

As previously reported, the Federal Communications Commission ("FCC") proposes to allot spectrum and adopt service and technical rules for new implanted medical devices that would expand the use of functional electric stimulation to restore sensation, mobility and function to paralyzed limbs and organs.

FCC adopts rules for new medical radio service
  • Paul Weiss
  • USA
  • March 27 2009

The FCC lent its support to the advancement of medical technology with the release of a Report and Order last Friday that establishes a new Medical Device Radiocommunication (MedRadio) Service under Part 95 of the agency’s rules.

Post-market surveillance: FDA’s “sentinel initiative” and related CMS rulemaking
  • Reed Smith LLP
  • USA
  • May 31 2008

On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System” a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market.

Stark rulemaking delayed, further comments sought
  • Squire Patton Boggs
  • USA
  • April 22 2008

As anticipated, the Centers for Medicare and Medicaid Services (CMS) again addressed substantial revisions to the Stark regulations.