Federal Register #FDA-2015-D-1580

FDA Guidance on Voluntary Patient Preference Information for Medical Devices

This notice announces the release of a final guidance document by the Food and Drug Administration (FDA) regarding voluntary patient preference information (PPI) in the medical device lifecycle. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or vendors are mentioned - Products/Services Requested: - No products or services are being procured - No part numbers or quantities are listed - Notable Requirements and Details: - The guidance provides recommendations for collecting and submitting patient preference information (PPI) to the FDA - Applies to a range of medical device regulatory submissions, including IDE, PMA, HDE, De Novo, and 510(k) processes - Offers principles for including PPI in decision summaries and device labeling - Aims to enhance FDA decision-making by incorporating patient input throughout the device development and regulatory review process - No procurement action, contract, or purchase is associated with this notice

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance document titled "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle." This guidance outlines principles and recommendations for collecting and submitting patient preference information (PPI) to FDA, its inclusion in decision summaries, and device labeling. It applies across the total product life cycle of medical devices, including investigational device exemption applications, breakthrough device designation requests, premarket approvals, humanitarian device exemptions, De Novo classification requests, and premarket notifications. The guidance aims to enhance FDA decision-making by incorporating valuable patient input throughout device development and regulatory review.

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