Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50887 

Dated: September 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19689 Filed 9–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0881] 

Consolidation of Devices That Process 

Autologous Human Cells, Tissues, and 

Cellular and Tissue-Based Products at 

the Point of Care To Produce a 

Therapeutic Article 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

consolidating regulatory oversight 

responsibilities in the Center for 

Biologics Evaluation and Research 

(CBER) for certain devices that process 

autologous human cells, tissues, and 

cellular and tissue-based products 

(HCT/Ps) at the point of care where the 

device output is intended to mediate the 

intended therapeutic effect. To support 

this consolidation effort, fat transfer 

devices (described further below) with 

the product code MUU that are 

currently regulated by the Center for 

Devices and Radiological Health (CDRH) 

will be transferred to CBER for 

regulation. This action affects only 

center assignment. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5130, Silver Spring, 

MD 20993, 301–796–8941, john.weiner@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Consolidation in CBER of Devices 

That Process Autologous Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products at the Point of Care To 

Produce a Therapeutic Article 

FDA is consolidating regulatory 

oversight responsibilities in CBER for 

devices that process autologous human 

cells, tissues, and cellular and tissuebased products (HCT/Ps) at the point of 

care to produce a therapeutic article. To 

support this consolidation effort, fat 

transfer devices (described further 

below) with the product code MUU that 

are currently regulated by CDRH will be 

transferred to CBER for regulation. This 

action affects only center assignment. 

FDA has the authority to regulate 

devices as defined under section 201(h) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 321(h)). Devices may be 

regulated by CDRH or CBER (see, e.g., 

Ref.1). 

In July 2007, the Agency published 

the final guidance ‘‘Devices Used to 

Process Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps)’’ to assist sponsors in 

determining which center at FDA would 

have regulatory oversight for devices 

used at the point of care to process 

HCT/Ps (Ref. 2). Assignment of these 

devices is determined by whether the 

point-of-care device creates an HCT/P 

that is intended to mediate the intended 

therapeutic effect. Point-of-care devices 

that process autologous materials are 

assigned to CBER when the intended 

therapeutic effect is mediated by the 

biological output of the device. For 

example, a cell sorter that is used to 

isolate CD34+ cells from bone marrow 

for use in hematopoietic reconstitution 

is assigned to CBER for review and 

regulation because the cellular output of 

the device is intended to provide the 

intended therapeutic effect. 

Since the publication of the 2007 

guidance, assignment of point-of-care 

devices intended to process HCT/Ps has 

generally been consistent with that 

guidance, with a few exceptions. Under 

21 CFR 878.5040, a suction lipoplasty 

system is a Class II device that is 

intended for aesthetic body contouring 

and consists of a powered suction pump 

(containing a microbial filter on the 

exhaust and a microbial in-line filter in 

the connecting tubing between the 

collection bottle and the safety trap), 

collection bottle, cannula, and 

connecting tube. These devices act by 

removal of unwanted fat from areas of 

the body. 

However, fat transfer devices, that is, 

devices that process adipose tissue for 

return to the body, have also been 

regulated at CDRH and assigned the 

same product code, MUU, as suction 

lipoplasty systems. While suction 

lipoplasty devices for fat removal do not 

produce an article for return to the body 

in order to mediate an intended 

therapeutic effect, the output of fat 

transfer devices is returned to the body 

in order to mediate the intended 

therapeutic effect (e.g., administration of 

fat for the purpose of body contouring). 

Accordingly, we are transferring fat 

transfer devices identified by product 

code MUU to CBER so that these 

devices are regulated by the same center 

that regulates other devices that process 

HCT/Ps where the device output (HCT/ 

P) mediates the intended therapeutic 

effect. 

This transfer does not include the 

suction lipoplasty devices previously in 

product code MUU that are solely 

intended to remove fat for discard for 

the purpose of body contouring. These 

devices have been assigned a new 

product code, QPB, and will continue to 

be regulated by CDRH. For the 

transferred MUU products, submissions, 

communications, and required reports 

should be directed to CBER. 

Submissions, communications, and 

required reports for the QPB products 

should continue to be directed to CDRH. 

Additionally, CDRH will continue to 

handle submissions under review or on 

hold (i.e., received prior to the 

publication date of this Federal Register 

document) for MUU products until a 

final decision is reached. Subsequent 

submissions for MUU products will be 

directed to CBER. 

II. Reference 

The following references are on 

display in the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500 

and is available for viewing by 

interested persons between 9 a.m. and 4 

p.m., Monday through Friday; it is also 

available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. SMG (FDA Staff Manual Guides) 

1410.406, ‘‘Determination of 

Classification of Devices,’’ November 13, 

2018. https://www.fda.gov/media/80114/ 

download. 

2. ‘‘Guidance for industry and FDA staff 

Devices Used to Process Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps),’’ July 2007. https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/devicesused-process-human-cells-tissues-andcellular-and-tissue-based-productshctps. 

Authority: 21 U.S.C. 321(h). 

Dated: August 27, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18912 Filed 9–10–21; 8:45 am] 

BILLING CODE 4164–01–P 


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