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# 2 Final Guidances on Regenerative Medicine
- URL: https://www.fdaweb.com/2-final-guidances-on-regenerative-medicine/
- Published: 2019-02-15T12:00:00.000Z
- Updated: 2026-09-15T01:04:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143401

FDA has finalized two guidance documents on regenerative medicine therapies that were issued as drafts 11/2017 as part of the agency’s [comprehensive regenerative medicine policy framework](https://c212.net/c/link/?t=0&l=en&o=2377074-1&h=56141213&u=https%3A%2F%2Fwww.fda.gov%2FNewsEvents%2FNewsroom%2FPressAnnouncements%2Fucm585345.htm&a=comprehensive+regenerative+medicine+policy+framework&ref=fdaweb.com). The first guidance, [Evaluation of Devices Used with Regenerative Medicine Advanced Therapies](https://c212.net/c/link/?t=0&l=en&o=2377074-1&h=1619537275&u=https%3A%2F%2Fwww.fda.gov%2Fdownloads%2FBiologicsBloodVaccines%2FGuidanceComplianceRegulatoryInformation%2FGuidances%2FCellularandGeneTherapy%2FUCM585417.pdf&a=Evaluation+of+Devices+Used+with+Regenerative+Medicine+Advanced+Therapies&ref=fdaweb.com), is intended to clarify how the agency will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). It specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.  
  
The second guidance, [Expedited Programs for Regenerative Medicine Therapies for Serious Conditions](https://c212.net/c/link/?t=0&l=en&o=2377074-1&h=1725522697&u=https%3A%2F%2Fwww.fda.gov%2Fdownloads%2FBiologicsBloodVaccines%2FGuidanceComplianceRegulatoryInformation%2FGuidances%2FCellularandGeneTherapy%2FUCM585414.pdf&a=Expedited+Programs+for+Regenerative+Medicine+Therapies+for+Serious+Conditions&ref=fdaweb.com), describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new [(RMAT) designation](https://c212.net/c/link/?t=0&l=en&o=2377074-1&h=2022148294&u=https%3A%2F%2Fwww.fda.gov%2FBiologicsBloodVaccines%2FCellularGeneTherapyProducts%2Fucm537670.htm&a=Regenerative+Medicine+Advanced+Therapy+%28RMAT%29+designation&ref=fdaweb.com) created by the 21st Century Cures Act. In addition, the document describes the regenerative medicine therapies that may be eligible for RMAT designation.