Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA has developed this 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 quality1 and patient safety. This 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 fact-specific. However, FDA believes that explaining how we consider the factors listed in this 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1495.