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Results:1-10 of 46

Minnesota Court Excludes Plaintiff Expert Opinions For Lack of General Acceptance
  • Reed Smith LLP
  • USA
  • March 21 2018

All of us - defense lawyers, plaintiff lawyers, and judges - tend to assume that the federal Daubert standard for admissibility of expert testimony is


Pitfalls Of Judges, Lawyers, And Experts Citing Wikipedia
  • Reed Smith LLP
  • USA
  • January 23 2017

Our weekly search for new drugmedical device cases for 11317 turned up something unusual - not of particular substantive significance, but unusual


The Difference Between Manufacturing and Design Defects
  • Reed Smith LLP
  • USA
  • June 30 2016

Some plaintiffs seem to think that if they allege any problems about anything in the manufacturing process of a prescription medical product, then it


House approves ACA device tax repeal bill in face of veto threat
  • Reed Smith LLP
  • USA
  • June 8 2012

Yesterday the House approved by a vote of 270-146 legislation to repeal the ACA’s controversial 2.3 excise tax on the sale price of certain medical devices, which is scheduled to apply to sales after December 31, 2012.


Increased scrutiny for the 510(k) process
  • Reed Smith LLP
  • USA
  • November 17 2011

On November 14, 2011, the Senate Health, Education, Labor and Pensions Committee held a hearing called "Medical Devices: Protecting Patients and Promoting Innovation."


CMS and FDA publish parallel review pilot program notice
  • Reed Smith LLP
  • USA
  • October 11 2011

On Friday, October 7, 2011, the Centers for Medicare & Medicaid Services (“CMS”) and the Food and Drug Administration (“FDA”) (collectively, the “Agencies”) announced they were soliciting nominations from sponsors of medical devices to participate in the Agencies’ parallel review pilot program


Prospects unclear for CMSFDA proposed parallel review of medical products
  • Reed Smith LLP
  • USA
  • August 2 2011

Notably absent from last month’s Department of Health and Human Services Semiannual Regulatory Agenda was any indication of where the Centers for Medicare and Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") stand with respect to their notice with request for comments, issued last fall, on the proposed parallel review process for medical products.


FDA issues draft guidance regarding mobile medical applications
  • Reed Smith LLP
  • USA
  • July 26 2011

On July 19, 2011 the FDA released a draft guidance document regarding the use and oversight of mobile medical applications.


Parallel CMSFDA review of medical products
  • Reed Smith LLP
  • USA
  • September 17 2010

On September 17, 2010, CMS and FDA published a notice announcing that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review.


Convergence of communications and medical systems: the opportunities and the challenges
  • Reed Smith LLP
  • USA
  • June 18 2010

The Federal Communications Commission (FCC) just announced that, as part of its implementation of the recently released National Broadband Plan and the Plan's recommendation to use the power of broadband to improve healthcare, the FCC and the Food and Drug Administration (FDA) are going to be holding a public meeting on July 26 and 27, 2010, to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices.