11 July 2016 - Federal regulatory frameworks governing medical products are designed to provide evidence that a product benefits patients when used as intended and should be available despite accompanying risks and ensure timely access to needed therapies and diagnostics.

Historically, policy makers and product developers have viewed these objectives as being in tension. However, ensuring safety, expediting patient access, and enabling innovation can be complementary goals within a regulatory framework for medical devices.

The US standard for marketing a medical device is “reasonable assurance of safety and effectiveness” (RASE). Generally, clinical studies must be conducted to demonstrate RASE for both high-risk and innovative lower-risk devices and US patients and clinicians have greater assurances that the benefits of devices outweigh the potential risks. In contrast, other countries apply a standard of safety and performance with limited clinical data.

The greater evidentiary burden of RASE may create disincentives for manufacturers to bring important medical devices to the United States or may delay access to devices. For example, the first transcatheter aortic valve replacement device was available for clinical use in Europe several years before it was available in the United States. However, there are examples of unsafe and ineffective devices that never made it to the US market; these can be found in a report from the US FDA.

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