21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.
(2) You must submit to FDA a list of each HCT/P manufactured; and
(3) You must comply with the other requirements contained in this part.
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1271 after this date.
- 21 CFR 1271.390 — Applicability.
- 21 CFR 1271.330 — Applicability.
- 21 CFR 1271.420 — HCT/Ps Offered for Import.
- 21 CFR 1271.400 — Inspections.
- 21 CFR 1271.1 — What Are the Purpose and Scope of This Part?
- 21 CFR 1271.440 — Orders of Retention, Recall, Destruction, and Cessation of Manufacturing.
- 21 CFR 1271.20 — If My HCT/P's Do Not Meet the Criteria in § 1271.10, and I Do Not Qualify for Any of the Exceptions in § 1271.15, What Regulations Apply?
- 21 CFR 1271.25 — What Information Is Required for Establishment Registration and HCT/P Listing?
- 21 CFR 1271.370 — Labeling.
- 21 CFR 1271.350 — Reporting.