GUIDANCE DOCUMENT 
Devices Used to Process Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps)  
 
Guidance for Industry and FDA Staff 
 
July 2007 
 
Final 
Final  
Print 
 
 
Issued by: Office of the Commissioner, Office of Clinical Policy and Programs, Office of 
Combination Products 
 
For questions regarding this document, contact: 
Office of Combination Products 
301-796-8930 
 
Additional copies are available from: 
Office of Combination Products 
Food and Drug Administration 
WO32, Hub/Mail Room #5129, 
10903 New Hampshire Avenue, 
Silver Spring, MD 20993 
301-796-8930 
(Fax) 301-847-8619  
http://www.fda.gov/CombinationProducts/default.htm 
combination@fda.gov 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 
1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact 
title of this guidance document. Comments may not be acted upon by the Agency until the 
document is next revised or updated. 
     
TABLE OF CONTENTS 
I. Purpose 
 
II. Jurisdictional Information 
 
III. For further information 
This guidance represents the Food and Drug Administration's (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. You can use an alternative approach if the approach satisfies the requirements 
of the applicable statutes and regulations. If you want to discuss an alternative approach, contact 
the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate 
FDA staff, call the appropriate number listed on the title page of this guidance. 
Purpose 
 
This guidance is intended to improve the transparency of FDAs jurisdictional determinations by 
providing detailed information about the classification and assignment of certain products. The 
jurisdictional information contained in this guidance document may be based on a past decision 
made in response to a Request for Designation submitted pursuant to 21 CFR Part 3, or in 
response to a request for an informal jurisdictional determination. FDAs Office of Combination 
Products (OCP) issues jurisdictional updates on selected classes of products on an ongoing basis. 
OCP selects products to be the subject of jurisdictional updates based on its perception of the 
current level of interest in the jurisdictional issue, the extent to which the class of products can be 
clearly described, the extent to which the existence and description of the class of products has 
been made public, and related factors. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
Jurisdictional Information 
 
FDA has received requests for designation (RFDs) for devices intended to process human cells, 
tissues, or cellular and tissue-based products (HCT/Ps) at the point of care. A frequently asked 
question in these RFDs has been whether the device should be assigned to the Center for 
Biologics Evaluation and Research (CBER) or the Center for Devices and Radiological Health 
(CDRH) for review and regulation.   
Devices intended to process HCT/Ps ex vivo to create a therapeutic article, that is, products 
where the intended therapeutic effect is mediated by the biologic output of the device, have been 
assigned to CBER. For example, cell sorters used at the point of care to isolate and/or 
concentrate autologous stem cells or hematopoietic progenitor cells for in vivo use have been 
assigned to CBER for review under the device provisions of the Federal Food, Drug, and 
Cosmetic Act (the Act), or the Public Health Service (PHS) Act. Similarly, devices that process 
autologous blood or tissue to produce a new HCT/P (e.g., a tissue engineered, live cell construct) 
at the point of care, for direct re-administration to that patient have also been assigned to CBER 
for review. CBER should be consulted for further information about the regulatory pathway for 
such products, including information on the review and regulation of the HCT/P.1 
 
In contrast, cell sorters designed to isolate or concentrate a specific cell population have been 
assigned to CDRH for review under the device provisions of the Act when the sorted cells are 
intended only for in vitro diagnostic use. The labeling of these products typically limits them to 
in vitro diagnostic use and the output material is not evaluated for suitability for 
readministration. 
 
For further information 
 
For an informal determination whether a particular device will be assigned to CBER or CDRH 
contact: 
 
Center for Biologics Evaluation and Research (CBER) Center Contact: 
Sheryl Lard Whiteford, Ph.D. 
Email: CBERProductJurisdiction@fda.hhs.gov 
Telephone: 240-402-7912  
 
or 
 
Center for Devices and Radiological Health (CDRH) Center Contact: 
James Bertram, PhD. 
E-mail: CDRHProductJurisdiction@fda.hhs.gov 
Telephone: 301-796-9588 
 
or 
 
The Office of Combination Products may also be contacted at 
Food and Drug Administration 
WO32, Hub/Mail Room #5129, 
10903 New Hampshire Avenue, 
Silver Spring, MD 20993 
301-796-8930 
Email: combination@fda.gov 
  A formal determination of the assignment of a particular product may be made through the RFD 
process. Further information about the RFD process is available at 21 CFR Part 3  and in the 
document Guidance for Industry and FDA: How to Write a Request for Designation (RFD), 
available at www.fda.gov/oc/combination/. It is recommended that sponsors call OCP at 301-
796-8930 to discuss their particular situation before submitting an RFD. 
 
OCP is always available as a resource to you. We encourage you to contact OCP if you have any 
questions about the jurisdiction of your product. 
 
Footnote: 
1 For example, see Guidance for Industry, Cell Selection Devices for Point of Care Production of Minimally 
Manipulated Autologous Peripheral Blood Stem Cells (PBSCs) at http://www.fda.gov/cber/gdlns/pbsc.htm.