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Compliance In Focus
Posted by John Lehmann on Thu, Aug 23, 2012

Is the US Faster in Bringing High-Risk Devices to Market?

There has been a consistent criticism that it takes longer to have a high-risk medical device inQuick High Risk Devices (2) the United States than in Europe.  This argument has been used to bolster an argument that the FDA should lower its standards for approving medical devices, which is denying Americans access to innovative technology. According to an article in the New England Journal of Medicine this might not be the case.  It points out that a review of data suggests it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the U.S. as it does in the four largest European markets (Germany, France, Italy and Britain).

Authors Saphtarshi Basu, MPA and John C. Hassenplug, MSc, point out three key criteria that should be used in comparing the U.S. and European Systems.  They are as follows:

  1. Focus on Innovative, High-Risk Devices – the device requires the strongest evidence of clinical benefits in the U.S.
  2. An Accurate Comparison of Time to Market Access – what is the total time that elapses between application submission and market access.
  3. Patient Access Should be Equated with the Availability of Reimbursement Rather than with Device Approval.

The article includes a great overview graph of the comparison of time to market in premarket approval and reimbursement processes pointing out that patient access is often delayed until reimbursement decisions are made, which generally take longer in Europe.

By using these equivalent standards it makes it easier to make accurate comparisons between countries.  Do you agree with their assessment?  If not, let us know what you think.

Photo Credit: selectagold


Topics: High-Risk Devices, New England Journal of Medicine, United States


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