According to a recent analysis by EP Vantage, there was a 44% reduction in the number of devices approved by the FDA in 2013, as compared to 2012. There are a few key factors that should be considered with respect to this decline.
The number of mergers and acquisitions within the medical device field has dropped markedly; this has hampered research and development (R&D) efforts. There has also been a general climate of cautious spending as the new healthcare legislation is rolled out. As US economic progress continues and implementation of healthcare reform unfolds, there is reason to believe that R & D will increase.
Another pertinent factor is the increasingly stringent FDA approval process. This is especially true for significant-risk devices that must obtain premarket approval (PMA). As trial requirements are tightened up, criteria for device approval become more complex and demanding. The FDA has already started to develop programs (e.g. the new de novo pathway) to expedite the review process and increase the number of approved devices.
The combination of increased R&D and a more streamlined FDA review process has the potential to increase the number of approved devices. If this potential is not realized, the European market may play a larger role in device development. As devices in Europe are approved under a less rigorous CE marking system, approval is often more quick and less expensive than in the US. While larger device companies may be able to afford the time and resources necessary to secure FDA approval, smaller companies may not have the same capability. This could lead smaller companies to seek initial European approval in order to demonstrate the device on the European market prior to pursuit of FDA approval.
How could this affect the US market? How could this affect patients? Sponsors?
Please share your thoughts!
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