New Draft Guidance Outlines FDA’s Proposed Framework to Collect and Use Patient Preference Information in Device Submissions and Labeling

On May 13, 2015, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo  Requests, and Inclusion in Device Labeling (Draft Guidance), discussing the collection and submission of patient preference information that may be used by FDA in decision-making relating to premarket approval applications (PMAs), Humanitarian Device Exemption (HDE) applications, and de novo requests.

Read more: New Draft Guidance Outlines FDA’s Proposed Framework to Collect and Use Patient Preference Information in Device Submissions and Labeling


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