Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry

Issue Date: February 15, 2019
Issued by: Center for Biologics Evaluation and Research
Topic(s): Combination Products, Gene Therapy
Status: Final

Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry

This guidance provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with FDA’s current thinking regarding evaluation of devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies.

Download the Guidance Document

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