# 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 - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/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/4183697f-cc20-45d7-8bac-c59db5807fae

> FDA guidance document: 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. Issue date: August 24, 2016. Get complete insights and analysis.

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## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2016-08-24
- Last Changed: 2020-10-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-1580">FDA-2015-D-1580</a>

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