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The US FDA and medical device regulation: impact on innovation

机译：美国FDA和医疗器械法规：对创新的影响

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摘要

Those of us who have dedicated our lives to developing therapies and technologies that improve patient care have never been more concerned for the state of medical technology innovation and patient care in the US. Over the past few years, we have seen a steep decline in innovative new medical technologies reaching the marketplace, as it has become increasingly more difficult, more time consuming, more costly and less predictable to navigate the Food and Drug Administration's pre-market review process. Now more than even investors are reconsidering their investments in medical technology, companies are moving overseas or closing their doors, and US patients are being denied timely access to safe and effective new medical products. If this situation does not improve immediately, a generation of innovations and businesses will be lost along with the jobs they would have created and the lives they would have saved or improved.
机译：我们中那些致力于开发可改善患者护理的疗法和技术的人从未如此关注美国的医疗技术创新和患者护理状况。在过去的几年中，我们发现创新的新医疗技术进入市场的数量急剧下降，因为在食品和药物管理局的上市前审查过程中，它变得越来越困难，更加耗时，成本更高且难以预测。 。现在，甚至有更多的投资者正在重新考虑对医疗技术的投资，公司正在向海外转移或关门，美国患者也被拒绝及时获得安全有效的新医疗产品。如果这种情况不能立即得到改善，那么一代创新和业务将会流失，他们将创造的工作机会以及他们将挽救或改善的生活。

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