When do I register, submit an HCT/P list, and submit updates?

  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. When do I register, submit an HCT/P list, and submit updates?

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§ 1271.21 When do I register, submit an HCT/P list, and submit updates?

(a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations or within 30 days of the effective date of this regulation, whichever is later.

(b) You must update your establishment registration annually in December, except as required by § 1271.26. You may accomplish your annual registration in conjunction with updating your HCT/P list under paragraph (c) of this section.

(c)

(i) If no change described in § 1271.25(c) has occurred since you previously submitted an HCT/P list, you are not required to update your listing.

(ii) If a change described in § 1271.25(c) has occurred, you must update your HCT/P listing with the new information:

(a) At the time of the change, or

(b) Each June or December, whichever month occurs first after the change.

[69 FR 68681, Nov. 24, 2004]


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