Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance

V. ADDITIONAL INFORMATION

1. How Can I Get More Information About the Appropriate Regulatory Considerations for My HCT/P from Adipose Tissue?

   The Agency provides two mechanisms through which a manufacturer may obtain a recommendation or decision regarding the classification of an HCT/P:

   1. The Tissue Reference Group, a group comprised of representatives from CBER and the Center for Devices and Radiological Health (CDRH), provides product sponsors with an informal process through which they may obtain an Agency recommendation regarding the application of the criteria in 21 CFR 1271.10(a) to their HCT/Ps for a given indication. Information about this process as well as what you may want to include to facilitate review of your request can be found at: http://www.fda.gov/BiologicsBloodVaccines/ TissueTissueProducts/RegulationofTissues/ucm152857.htm
   2. A Request for Designation (RFD) may be submitted to the Office of Combination Products (OCP) to obtain a formal Agency decision regarding the regulatory identity or classification of an HCT/P (21 CFR Part 3). A description of that process and information on how to submit an RFD can be found at: http://www.fda.gov/CombinationProducts/RFDProcess/default.htm. Additional information may be found at http://www.fda.gov/Regulatoryinformation/Guidances/ucm126053.htm. You may also contact OCP to obtain an informal classification for your HCT/P.

   You may use either one of these mechanisms to obtain a response to a question as to whether your adipose tissue-derived HCT/P is regulated solely under section 361 of he PHS Act and 21 CFR Part 1271, or if it meets one of the exceptions in 21 CFR 1271.15.

2. How Can I Get More Information About the IND Process for My HCT/P from Adipose Tissue that Requires Premarket Approval?

   Further information about IND requirements for biological products may be obtained through the Regulatory Management Staff, Office of Cellular, Tissue, and Gene Therapies, at 240-402-8190 or [email protected].

3. How Do I Register as an HCT/P Manufacturer?

   FDA regulations require establishments that perform one or more steps in the manufacture of HCT/Ps to register and submit a list the products with the Agency. If you are a manufacturer that is required to register, you must do so within 5 days after beginning operations (21 CFR 1271.21(a)). Registrations must be updated annually in December, except if the ownership or location of the establishment changes, you must submit an amendment to the registration within five days of the change (21 CFR 1271.21(b)).

   FDA has created Form FDA-3356, Establishment Registration and Listing for HCT/Ps, for establishments to submit HCT/P establishment registration and listing information to FDA. The form can be submitted electronically, (Electronic Human Cell and Tissue Establishment Registration (eHCTERs). Instructions for completing the electronic registration form are located on our website, http://www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/ TissueEstablishmentRegistration/ucm148775.htm. Form FDA-3356 may also be completed and submitted by mail. Questions about HCT/P registration can be directed to: [email protected].

Return to Table of Contents

FOOTNOTES

¹ The term “manufacture” means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and the screening or  testing of the cell or tissue donor (21 CFR 1271.3(e)).

²Chapter 6. Adipose Tissue. In: Mescher AL. eds. Junqueira’s Basic Histology: Text Atlas, 13e. New York: McGraw-Hill; 2013. http://accessmedicine.mhmedical.com/content.aspx?bookid=574Sectionid=42524592.
 

³Brown SA, Levi, B, Lequeux, C, et al. Basic Science Review on Adipose Tissue for Clinicians. Plast. Reconstr. Surg. 126:1936, 2010

⁴When the Agency initially proposed this exception, FDA explained that basic function of a structural tissue is what the tissue does from a biological/physiological point of view, or is capable of doing when in its original state.  See “Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue Based Products, 63 Federal Register 26744 at 26749 (May 14, 1998).

⁵Some HCT/Ps from adipose tissue may be regulated as devices.  For more information about device regulation, see CDRH’s webpage Device Advice – Overview of Medical Device Regulation (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm).  Refer to section V.A below regarding obtaining more information about the regulatory considerations of your HCT/P from adipose tissue.

⁶For more information on this topic, you may wish to consult the draft guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b):  Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry” dated October 2014.  When finalized, this guidance will represent FDA’s current thinking on this topic.

Return to Table of Contents

 

• Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry (PDF – 107KB)