miércoles, 24 de agosto de 2016

CDRH Industry: FDA Issues Final Guidance on Patient Preference Information

Today, the U.S. Food and Drug Administration issued the final guidance document, "Patient Preference Information – Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.” Patient preference information can provide a unique and important perspective that can help the FDA evaluate the benefits and risks of certain medical devices. This final guidance encourages medical device manufacturers to voluntarily include in their premarket submissions information about the tradeoffs patients may consider when evaluating the benefits and risks of a treatment option. This effort is part of our Partner with Patients CDRH 2016-2017 Strategic Priority.
Patients are at the heart of everything we do, and we consider information about their preferences during our decision-making for medical devices. In considering the patient perspective, we remain committed to assuring that devices meet the requisite standards.This guidance does not change the review standards for PMAs, HDE applications, or de novo requests.  
This final guidance outlines:
  • Recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and patient advocacy organizations, can voluntarily collect and submit to FDA patient preference information.
  • How the FDA includes patient preference information in FDA’s decision summaries that explain what information the FDA relied on in its approval or marketing authorization of the product.
The FDA has updated the 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 to ensure consistency with the terminology and concepts presented in this guidance, including  the addition of information about PPI in the Benefit-Risk worksheet that FDA staff uses to guide benefit-risk determinations of PMAs and de novo requests.
The FDA will host a webinar for sponsors on Tuesday, September 27, 2016, and will send additional information about how to participate in the webinar closer to the date.  Information about the webinar will also be made available on CDRH’s webinar webpage.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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