Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry February 2019
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthOffice 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6154.