FDA has developed this draft guidance document to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. This draft guidance is not intended to limit FDA action; rather, it describes the general framework for medical device decision making in the product availability, compliance, and enforcement arenas. Product availability and other medical device compliance and enforcement decisions are generally 88 fact-specific. However, FDA believes that explaining how we consider the factors listed in this draft guidance document will improve the consistency and transparency of these kinds of decisions. A common understanding of how FDA considers benefit and risk may better align industry’s and FDA’s focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients.

 

This draft guidance, when finalized, is intended to provide a framework for FDA and stakeholders that sets forth overarching benefit-risk principles. FDA may consider the types of benefit-risk factors described in this draft guidance—including reliable patient preference information from a representative sample—on a case-by-case basis when determining the appropriate actions to take and to help ensure that informed and science-based decisions are made to the greatest extent practicable. Factors may be weighted differently for different types of decisions and as the timeframe allows. FDA intends to use pilots to help determine how to apply the benefit-risk framework described in this draft guidance.

In addition, this draft guidance, when finalized, is intended to harmonize FDA’s approach to weighing benefits and risks for medical device product availability, compliance, and enforcement decisions with FDA’s benefit-risk framework for assessing medical device marketing and investigational device exemption (IDE) applications. The benefit-risk factors in this draft guidance also support assessment of medical devices with real world evidence. While the benefit-risk factors in this draft guidance are not identical to the other frameworks, this draft guidance builds upon FDA’s premarket review benefit-risk policy in an effort to improve consistency in our patient centered approach and decision making across the total product life cycle. This draft guidance is intended to complement, not supplant, FDA’s “Guidance for Industry and Food and Drug Administration Staff – Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approvals and De Novo Classifications.”

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Posted on the FDA website on 16 June 2016