Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders August 2016
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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients. The Agency understands that patients and care-partners who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights into and perspectives on the benefits and risks of devices reviewed under the premarket approval, humanitarian device exemption (HDE), or de novo classification pathway. FDA believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices.
This kind of input can be important to consider during FDA’s decision making for these devices. For this reason, FDA’s guidance document “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” (hereafter referred to as the Benefit-Risk Guidance) explains that reviewers may consider certain data measuring patient perspectives during the premarket review process for premarket approval applications (PMAs) and de novo classification requests, when such information is available. That guidance specifies that patient tolerance for risk and perspective on benefit, in addition to several other factors, may be considered in FDA’s assessment of the benefit-risk profile of certain devices when the information qualifies as valid scientific evidence.
This guidance document takes the next step and provides guidance on patient preference information (PPI) that may be used by FDA staff in decision making related to PMAs, HDE applications, and de novo requests.
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:
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-2015-D-1580.