- September 26, 2016
08:00 PM - 08:00 PM EDT
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 hosted 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 responded to questions.
If you have any questions regarding this guidance document, please contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health