§ 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?

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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:

The HCT/P is minimally manipulated;

The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;

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

Either:

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

The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:

Is for autologous use;

Is for allogeneic use in a first-degree or second-degree blood relative; or

Is for reproductive use.

If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:

You must register with FDA;

You must submit to FDA a list of each HCT/P manufactured; and

You must comply with the other requirements contained in this part.

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§ 1271.15 - Are there any exceptions from the requirements of this part?