Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling | Federal Regulations · Congress.wiki

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FDA

Open for Comments

FDA-2015-D-1580

Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling

Documents

Comments

Description

Draft Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; Availability

Key Dates

Comment Period OpensMay 18, 2015

Comment Period ClosesDec 6, 2024

Documents

Type	Title	Posted	Comments	Status
Notice	Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability FR Doc: 2026-06063	Mar 30, 2026

Comment Statistics

Total Comments

Keywords

2013-881

Patient Preference Information

Submission, Review in PMAs, HDE Applications

De Novo Requests

Inclusion in Device Labeling

Draft Guidance for Industry

Food and Drug Administration Staff

Other Stakeholders

Data from Regulations.gov