The FDA plans to publish a draft guidance in early 2018 clarifying what degree of "acceptable uncertainty" is allowable when evaluating medical devices during premarket review, FDA Commissioner Scott Gottlieb, MD, wrote in an agency blog post Dec. 11.
Here are four things to know about the proposed policy.
1. For medical devices subject to premarket review, the FDA's current regulatory process focuses on weighing the product's probable benefits against the potential risk of injury from its use. "As part of that analysis, FDA considers what level of uncertainty is acceptable about the product's probable benefits and risks before the device is available to the public," Dr. Gottlieb explained.
The FDA also requires post-market follow-up studies of medical devices, to illustrate the long-term performance — including benefits and drawbacks — of these products.
2. Dr. Gottlieb said the updated draft guidance will outline factors the agency considers when assessing "acceptable uncertainty," such as the extent of the public health need, seriousness of the illness the device treats and the size of the population that would benefit from the technology. Another consideration is whether the FDA will be able to obtain necessary pre- or post-market data.
For example, the "FDA might accept greater uncertainty for a device where gathering extensive clinical evidence premarket would not be feasible given the small patient population that the device is intended to treat," Dr. Gottlieb wrote.
3. Under this more "progressive" review framework, Dr. Gottlieb said the FDA will clarify when it's appropriate to place "greater reliance on postmarket data in order to facilitate access to certain innovation" in "transparent, consistent and objectively-defined" language. The ultimate goal of the new framework is to allow patients to gain faster access to appropriate devices, according to Dr. Gottlieb.
4. The FDA would use the proposed framework for all of its existing regulatory pathways for device manufacturers, including 510(k), De Novo, premarket approval application and humanitarian device exemption application.