In recent years, the field of regenerative medicine has gained significant traction and been pointed to as the future wave of medicine. Regenerative medicine focuses on replacing tissues or organs that have been damaged by disease or other conditions and includes the fields of tissue engineering, cellular therapies, and artificial organs. As part of the agency’s commitment to help bring new and innovative treatment options to patients, the FDA regulates regenerative medicine through its Center for Biologics Evaluation and Research (CBER)...

1. Regulating Regenerative Medicine
By: Madison Wheeler
In recent years, the field of regenerative medicine has gained significant traction and been
pointed to as the future wave of medicine. Regenerative medicine focuses on replacing tissues or
organs that have been damaged by disease or other conditions and includes the fields of tissue
engineering, cellular therapies, and artificial organs.1 As part of the agency’s commitment to help
bring new and innovative treatment options to patients, the FDA regulates regenerative medicine
through its Center for Biologics Evaluation and Research (CBER). Through CBER, the FDA
supports and expedites the development of human cells, tissues, and cellular/tissue-based
products (HCT/P’s) to treat and mitigate diseases.
The FDA established 21 CFR 1271 to institute the regulations that regenerative medicine
firms must comply with. This part establishes the classic regulations that most firms should be
familiar with such as general provisions including the scope and defined terms, procedures for
registration and listing, and exceptions. This part also outlines provisions specific to regenerative
medicine, such as donor eligibility and Current Good Tissue Practice.2 The regulatory
requirements around current good tissue practices govern the methods, facilities, and controls for
the manufacture of HCT/P’s. This includes all steps from recovery, donor screening/testing,
processing, storage, labeling, packaging, and distribution.3
Since the sector of regenerative medicine is fairly new, the FDA has established 4 final
guidance documents that define the regulatory framework for the field. The guidance documents
focus on not only helping firms determine if their HCT/P’s are subject to premarket reviews and
any exceptions under 21 CFR 1271, but also detail ways the agency is helping bring innovative,
safe, and effective HCT/P’s to patients as quickly as possible. An example of an expedited
program for regenerative medicine therapies is the RMAT (Regenerative Medicine Advanced
Therapy) designation program which, if a product is eligible, includes benefits like expedited
FDA review and supplemental interaction with the agency.4
The expanding field of regenerative medicine is a new and exciting addition to public
health and one that the FDA is still developing the regulatory framework for. If you are a firm
that is interested in exploring regenerative medicine, EMMA International has the expertise to
1 University of Pittsburgh (n.d.) Whatis RegenerativeMedicine? Retrievedon 07/27/2020 from: https://mirm-pitt.net/about-us/what-is-
regenerative-medicine/
2 FDA(n.d.) Title 21 Part 1271 HumanCells, Tissues, and Cellular andTissue-Based Products retrieved on 07/27/2020 from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271
3 FDA(March 2018) Good TissuePractice (CGTP) FinalRuleQuestions and Answers retrievedon 07/27/2020 from:
https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/good-tissue-practice-cgtp-final-rule-questions-and-
answers#:~:text=Current%20good%20tissue%20practice%20are,%2C%20storage%2C%20labeling%2C%20packaging%2C
4 FDA(February 2019) Expedited Programs for RegenerativeMedicineTherapies for Serious Conditions retrieved on 07/27/2020 from:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-regenerative-medicine-therapies-serious-
conditions

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