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

Name: 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
Creator: Food and Drug Administration
Keywords: applications,approval,decisions,exemptions,fda,guidances,humanitarian,inclusion,industry,labeling,patients,pre-market,pre-market-approval,requests,review,submissions,summaries

Information

Type

Guidance

Regulated products

Medical Devices, Radiation-Emitting Products

Published

August 24, 2016

Last updated

October 20, 2020

Description

This is a guidance document titled "Patient Preference Information" that provides instructions for industry and FDA staff on voluntary submissions and reviews in various applications.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

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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

Updated on October 20, 2020

pdf (765.7KB)

URL: https://www.fda.gov/media/92593/download
Permalink: https://data.openrid.co/en/datasets/r/e6227534-ceec-41e5-a786-a03e16d657cb
MIME Type: application/pdf

Created on: August 24, 2016
Modified on: October 20, 2020

Size: 765.7KB