Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
August 24, 2016
October 20, 2020
4183697f-cc20-45d7-8bac-c59db5807fae
Related Documents
Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJune 14, 2023Center for Devices and Radiological Health
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders
Guidance DocumentJanuary 26, 2022Center for Devices and Radiological Health
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
Guidance DocumentJanuary 26, 2022Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.