SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff.” The draft guidance document provides HCT/P manufacturers, healthcare providers, and FDA staff with recommendations for meeting the 21 CFR 1271.10(a)(1) criterion of minimal manipulation. The draft guidance, when finalized, is intended to supersede the document entitled “Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update” dated September 2006. Note that FDA intends to publish a separate draft guidance document on the criterion described in § 1271.10(a)(2), the HCT/P is intended for homologous use only as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent.

HCT/Ps are defined in § 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. FDA has implemented a risk-based approach to the regulation of HCT/Ps. Under the authority of section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264), FDA established regulations for all HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. These regulations can be found in part 1271. HCT/Ps are regulated solely under section 361 of the PHS Act and part 1271, if they meet all of the following criteria (21 CFR 1271.10(a)):

• 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 ( printed page 77013) 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 the following uses:

Autologous,

Allogeneic, in a first-degree or second-degree blood relative, or

Reproductive.

If an HCT/P does not meet all of the criteria set out under § 1271.10(a), the HCT/P will be regulated as a drug, device, and/or biological product under the Federal Food, Drug, and Cosmetic Act, and/or section 351 of the PHS Act (42 U.S.C. 262).

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 1271 have been approved under OMB control number 0910-0543.

III. Comments

The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES ). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, or http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm, or http://www.fda.gov/​CombinationProducts/​GuidanceRegulatoryInformation/​default.htm, or http://www.regulations.gov. Persons unable to download an electronic copy of the draft guidance entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and FDA Staff” may send an email request to CDRH-guidance@fda.hhs.gov to receive an electronic copy of the document.