Regenerative Medicine Consensus Standard Guidance

FDA has published a draft guidance, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, describing a CBER program designed to identify and recognize voluntary consensus standards to facilitate the development and assessment of regenerative medicine therapy products regulated by the Center. The document says CBER encourages the use of appropriate standards in the development of CBER-regulated products.

The guidance contains Introduction, Background, Scope, Purpose of the Program, Procedures for Evaluating Voluntary Consensus Standards for Recognition in the Standards Recognition Program for Regenerative Medicine Therapies, Documenting the Use of a Standard Recognized by CBER Under the Standards Recognition Program for Regenerative Medicine Therapies in a Regulatory Submission, Questions and Answers, References, and two Appendices.