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# Cell/Tissue Product eSubmission Instructions
- URL: https://www.fdaweb.com/cell-tissue-product-esubmission-instructions/
- Published: 2019-11-06T12:00:00.000Z
- Updated: 2026-09-14T15:52:08.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145432

CBER has posted a [document](https://www.fda.gov/media/109160/download?ref=fdaweb.com) providing “Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).” Establishments that manufacture such products are required to register and list their products electronically with FDA for the manufacturing steps they perform using eHCTERS (21 CFR Part 1271). Establishments that manufacture cell/tissue products regulated as devices, drugs, or biological drugs under Section 351 of the PHS Act or under the Food, Drug, and Cosmetic Act can no longer register in eHCTERS. Such establishments must register and list their products, after approval, in accordance with 21 CFR Part 207 or 807, FDA says.