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# Q & A Guide on Cell/Tissue Product Enforcement
- URL: https://www.fdaweb.com/q-a-guide-on-cell-tissue-product-enforcement/
- Published: 2021-07-12T12:00:00.000Z
- Updated: 2026-09-14T17:05:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149681

FDA has posted a [guidance](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or?ref=fdaweb.com) entitled *Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular- or Tissue-based Products (HCT/Ps)*. In answers to common questions, the agency says that beginning last month it no longer intends to exercise enforcement discretion with respect to the IND and premarket approval requirements for such products.  
  
“FDA expects all establishments that manufacture HCT/Ps regulated as drugs or biological products to have an approved biologics license application (BLA) or an investigational new drug application (IND) in effect,” the guidance says. “An approved BLA is required to lawfully market these products. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect.”