Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit electronic comments on the draft guidance to
There are many factors that go into weighing the probable benefit of a device versus its probable risk. This draft guidance sets out the factors FDA considers when making this determination and explains them in detail. This draft guidance also gives examples of how the factors interrelate and how they may affect FDA's decisions. By clarifying FDA's decisionmaking process in this way, we hope to improve the predictability, consistency, and transparency of the review process for applicable devices.
This draft guidance also includes for public comment a draft worksheet that reviewers may use in making benefit-risk determinations. The worksheet is attached as appendix A to the guidance. This level of documentation is very helpful to maintaining the consistency of review across the different review divisions and better assuring that an appropriate decision is reached.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent the Agency's current thinking on factors to consider when making benefit-risk determinations in medical device premarket review. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at
FDA tentatively concludes that this draft guidance contains no new collections of information. This draft guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231.
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