Today, the U.S. Food and Drug Administration issued the draft guidance, "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions." To fulfill its mission of protecting and promoting public health, the FDA accepts an appropriate amount of uncertainty in benefit-risk determinations to support certain premarket decisions for medical devices. This balance is already a feature of product review and the guidance is intended to make these considerations more transparent, consistent, and objectively-defined.
This draft guidance further elaborates on one of the critical factors for benefit-risk decision-making, uncertainty, which was originally described in FDA’s 2012 guidance “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.” Since the publication of that guidance, FDA has issued subsequent complementary guidances to describe and expand on how FDA will consider specific factors in premarket decision making for devices (for example, the 2016 guidance on patient preferences). This draft guidance describes FDA’s consideration of uncertainty when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence. This includes devices subject to premarket approval (PMA) applications, De Novo requests, and humanitarian device exemption (HDE) applications.
In premarket decision-making for devices, there inherently exists some degree of uncertainty around benefits and risks. This draft guidance establishes a framework for the consideration of uncertainty to provide greater scientific rigor and consistency for this aspect of benefit-risk decision-making. Two circumstances where greater uncertainty could be appropriate are Breakthrough Devices subject to PMA and devices intended for small patient populations subject to PMA. Pediatric populations are an example of small patient populations for which these concepts are particularly important. The policies in this draft guidance support FDA’s mission to promote the public health by fostering medical device innovation. Timely access to high quality, safe, and effective medical devices is an important measure of safety – and we believe this approach will help FDA continue to facilitate development of new devices that make less-invasive treatments possible and provide new options to patients whose conditions would have been considered untreatable in the past.
The benefit-risk framework and explanation of uncertainty provided in this draft guidance is intended to assure greater predictability, consistency and efficiency while using least burdensome principles.
The draft guidance:
- Elaborates on FDA’s consideration of the appropriate uncertainty in benefit-risk determinations for certain premarket submissions and provides factors considered in such determinations;
- Reemphasizes FDA’s flexible, patient-centric approach to assessing the benefit-risk profile of a medical device; and
- Provides examples of how uncertainty can be acknowledged and appropriately mitigated where FDA is likely to accept greater uncertainty in premarket decisions, such as Breakthrough Devices and devices intended for small patient populations subject to PMA.
If you have any questions regarding this draft guidance document, please contact Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by phone at 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health |
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