Announcing Draft Guidance on Patient Preference Information

Today the FDA posted a draft guidance document, Patient Preference Information - Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling. This draft guidance explains what manufacturers and other stakeholders should consider when choosing to collect patient preference information, which may inform FDA’s benefit-risk determinations in the review of Premarket approval (PMA) applications, HDE applications, and de novo classification requests.

The FDA will continue to determine if a medical device demonstrates a reasonable assurance of safety and effectiveness, considering submitted patient preference information along with other evidence from clinical and nonclinical testing, in our assessment of the benefits and risks of a device. We have provided hypothetical examples in this draft guidance of how we might consider patient preference information when making benefit-risk assessments.

Also in this guidance, we included recommendations on how manufacturers can incorporate patient preference information into device labeling for patients and health care professionals.

Release of this draft guidance is part of the FDA’s on-going commitment to incorporating patients’ preferences into our regulatory decision-making. We believe that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices. It does not represent a change in how the FDA reviews these types of submissions. Instead, it outlines how we consider the patient voice in our benefit-risk determinations.

Also as part of this commitment, we collaborated with the Medical Device Innovation Consortium on a Framework for incorporating patient preferences in the device total product lifecycle as well as a Catalog of Methodologies that may be used to study patient preference information. Both documents can be found at http://mdic.org/pcbr/.

We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health