Docket Number:
FDA-2017-D-6154
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

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.

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All written comments should be identified with this document's docket number: FDA-2017-D-6154.

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