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GAO Issues Report on Medical Device Pricing
02/03/2012
The Government Accountability Office (GAO) issued a report looking at the pricing and transparency of costs for certain medical devices, focusing on implantables such as stents and artificial knees...
MDMA Statement on Proposed Package for Medical Device User Fees
02/01/2012
WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the tentative agreement between FDA and industry...
MDMA Submits Comments on Coverage with Evidence Development to CMS
01/27/2012
MDMA recently submitted comments with the Centers for Medicare & Medicaid Services (CMS) about their efforts on Coverage with Evidence Development (CED).  "MDMA supports CMS's efforts to...
MDMA Response to the State of the Union Address
01/24/2012
WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement regarding President Obama’s State of the Union Address:  “...
New Study Highlights Challenges for American R&D
01/18/2012
  A new report by the National Science Board, the policymaking body for the National Science Foundation (NSF) detailed the strengths and weaknesses of America's R&D sector while noting the...
Reimbursement Issues Continue to Shape Agenda for 2012
01/12/2012
  In one of the first decisions for what is expected to be a uniquely challenging year for reimbursement policies, the Medicare Payment Advisory Commission (MedPAC) recommended that Medicare...
MDMA Hosting Member-Only Webinar on 2012's Public Policy Agenda
01/06/2012
On Thursday, January 19th, at 2pm ET/11am PT, MDMA will host an important Member-Only webinar to discuss the priorities for the year ahead.   This webinar will focus on the 2012 Public...
FDA Issues Several Draft Guidances Including 510(k) Paradigm, Appeals Process
01/02/2012
FDA issued numerous draft guidances over the past two weeks addressing various aspects of its proposed action plan. They included: 510(k) Paradigm Draft Guidance Product Code Draft Guidance Draft...
MDMA Statement on CMS’ Proposed Rule on Physician Payment Disclosure
12/14/2011
WASHINGTON – MDMA President and CEO Mark Leahey issued the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS) proposed rule on physician payment disclosure:“We...
Senators Introduce Legislation to Streamline de novo Process
12/07/2011
Senators Scott Brown (MA) and Kelly Ayotte (NH) introduced legislation this week to improve the de novo process for medical technology innovators, and to increase predictability in the regulatory...