jueves, 1 de septiembre de 2016

CDRH Industry: Final Guidance on Patient Preference Information– FDA Webinar on Tuesday, September 27, 2016

CLEAN version with no appendices

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On August 23, 2016, the FDA published the final guidance on Patient Preference Information – Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling It 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. It also outlines how the FDA includes patient preference information in our decision summaries that explain what information the FDA relied on in its approval or marketing authorization of the product. This guidance does not change the review standards for PMAs, HDE applications, or de novo requests.The Agency 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.  
Patients are at the heart of everything we do, and we consider information about their preferences during our decision-making for medical devices. This effort is part of our Partner with Patients CDRH 2016-2017 Strategic Priority.
The FDA will host a webinar for manufacturers and other interested stakeholders to discuss this final guidance on Tuesday September 27, 2016.   Following a brief presentation on the information provided in the final guidance, the FDA will respond to questions.
Webinar details:
Registration is not necessary.
  • Date:  Tuesday, September 27, 2016
  • Time: 1:00 PM – 2:30 PM ET
  • To hear the presentation and ask questions:
    • Dial: 888-989-3485; passcode: 2624188
    • International: 1-415-228-4883 ; passcode: 2624188;
    • Conference number: PW9776744
  • To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW9776744&p=2624188&t=c
Following the webinar, a transcript, recording and slides will be available on CDRH’s webinar webpage. The slide presentation will be available at this site on the morning of the webinar.
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.

Food and Drug Administration
Center for Devices and Radiological Health 

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