January 17, 2017
Authored and Edited by Alexander M. Boyer; Susan Y. Tull
On January 13, 2017, FDA released a nonbinding draft Guidance, Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs. The Guidance is intended to clarify factors used by FDA when assessing the risks, anticipated benefits, and the inadequacy or uncertainty of data in a decision to approve or disapprove an IDE study. The factors are used as part of a benefit-risk framework supporting IDE decision-making, taking into account the inherent uncertainty of investigational device studies while recognizing the potential benefits to the public and the knowledge to be gained.
The factors outlined in the Guidance include (1) assessment of risks to study subjects; (2) assessment of other risks, including risks associated with misinterpretation of data from the study and risks to others during the study; (3) assessment of direct benefits to subjects in the study; (4) assessment of benefits to others from the study, including knowledge to be gained and information that may contribute to the development of a treatment; and (5) assessment of other factors contributing to risks and benefits of the study and the device, including knowledge and available evidence, the contextual setting in which the study is being proposed (e.g., characterization of the disease or condition being treated or diagnosed), and availability of alternatives and the risks associated with them. The factors above are divided into several subfactors that may be used in the FDA assessment.
FDA may disapprove of an IDE application if, overall, the risks to subjects outweigh the anticipated benefits and the importance of the knowledge to be gained. Therefore, FDA proposes these factors in order to provide a common framework and structured approach for assessing IDE benefits and risks. In doing so, the ability of sponsors to submit relevant evidence and information in IDE applications is improved, and FDA’s IDE decision-making process has greater predictability, consistency, and transparency. Finally, the Guidance recommends IDE sponsors provide as part of their IDE applications a brief section summarizing the sponsor’s benefit-risk assessment, guided by the Guidance factors and outlined in Appendix A of the Guidance. This provides FDA a concise synopsis of the sponsor’s consideration of the Guidance factors and where supporting information and evidence can be found in the IDE application.
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