How do I register and submit an HCT/P list?

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Regulations Under Certain Other Acts Administered by the Food and Drug Administration
  6. Human Cells, Tissues, and Cellular and Tissue-Based Products
  7. Procedures for Registration and Listing
  8. How do I register and submit an HCT/P list?

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§ 1271.22 How do I register and submit an HCT/P list?

(a) You must use the electronic registration and listing system at http://www.fda.gov/cber/tissue/tisreg.htm in accordance with § 1271.25 for:

(1) Establishment registration,

(2) HCT/P listings, and

(3) Updates of registration and HCT/P listing.

(b) FDA will periodically issue guidance on recommended procedures for providing registration and listing information in electronic format (for example, method of transmission, media, file formats, preparation, and organization of files).

(c) You must provide the information under paragraph (a) of this section in accordance with part 11 of this chapter, except for the requirements in § 11.10(b), (c), and (e) and the corresponding requirements in § 11.30.

[81 FR 60223, Aug. 31, 2016]


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