[Federal Register Volume 72, Number 21 (Thursday, February 1, 2007)]
[Rules and Regulations]
[Pages 4637-4638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. 2007N-0024]


Medical Devices; Hematology and Pathology Devices; Classification 
of Cord Blood Processing System and Storage Container

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying a cord 
blood processing system and storage container into class II (special 
controls). The special control that will apply to this device is the 
guidance document entitled ``Class II Special Controls Guidance 
Document: Cord Blood Processing System and Storage Container.'' FDA is 
classifying this device into class II (special controls) in order to 
provide a reasonable assurance of safety and effectiveness of this 
device. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of the guidance document that will serve as 
the special control for this device.

DATES: This rule is effective March 5, 2007. The classification of this 
device into class II became effective on January 3, 2007.

FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments), generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless and 
until the device is classified or reclassified into class I or II, or 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. FDA determines whether new 
devices are substantially equivalent to predicate devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and 21 CFR part 807 of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device. Within 30 days after the issuance of an order classifying the 
device, FDA must publish a notice in the Federal Register announcing 
such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on October 6, 2006, classifying into class III the Biosafe SA 
Sepax Cell Separation System and single use kits because this device is 
not substantially equivalent to a device that was introduced or 
delivered for introduction into interstate commerce for commercial 
distribution before May 28, 1976, or to a device which was subsequently 
reclassified into class I or class II. On November 1, 2006, Biosafe SA 
submitted to FDA a petition requesting classification of the Sepax Cell 
Separation System and single use kits under section 513(f)(2) of the 
act. The manufacturer recommended that the device be classified into 
class II (Ref. 1).
    In accordance with 513(f)(2) of the act, FDA reviewed the petition 
in order to classify the device under the criteria for classification 
set forth in 513(a)(1) of the act. Devices are to be classified into 
class II if general controls, by themselves, are insufficient to 
provide reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
petition, FDA determined that the Biosafe SA Sepax Cell Separation 
System and single use kits, when used in the processing and the storage 
of cord blood, can be classified into class II with the establishment 
of special controls. FDA believes that special controls, in addition to 
general controls, are adequate to provide reasonable assurance of the 
safety and effectiveness of this device and that there is sufficient 
information to establish special controls to provide such assurance.
    This device is assigned the generic name ``cord blood processing 
system and storage container.'' It is identified as a device intended 
for use in the processing and the storage of cord blood. This device is 
a functionally closed processing system that includes containers, other 
soft goods, and a centrifugation system for cord blood concentration, 
and a final container for the cryopreservation and the storage of a 
cord blood product.
    FDA has identified the risks to health associated with the use of a 
cord blood processing system and storage container. These risks include 
lack of biocompatible components; toxicity of residual chemical 
sterilants used to sterilize device components; toxicity of leached 
materials from or that permeate through plastic device components; 
insufficient mechanical strength of device containers, tubing, and 
seals resulting in integrity failure of the device; contamination; 
instability of soft goods over time; physical damage to or loss of the 
cord blood product; software failure; operator/user injury; 
electromagnetic interference; and electrical hazards.
    FDA believes that the class II special controls guidance document 
will aid in mitigating the potential risks to health by providing 
recommendations for describing the device, validating performance 
characteristics, and labeling. The guidance document provides 
recommendations for fulfilling the premarket (510(k)) submission 
requirements for this device. FDA believes that the special controls 
guidance document, in addition to general controls, addresses the risks 
to health identified in the previous paragraph and provides reasonable 
assurance of the safety and effectiveness of a cord blood processing 
system and storage container. Therefore, on January 3, 2007, FDA issued 
an order to the petitioner classifying the device into class II. FDA is 
codifying this device classification at 21 CFR 864.9900.
    Following the effective date of this final classification rule, 
manufacturers submitting a 510(k) premarket notification for a cord 
blood processing system and storage container will need to address the 
issues covered in the

[[Page 4638]]

special controls guidance. However, the manufacturer need only show 
that its device meets the recommendations of the guidance or in some 
other way provides equivalent assurance of safety and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements under section 
510(k) of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of this type of device and, therefore, this type of 
device is not exempt from premarket notification requirements. Persons 
who intend to market this type of device must submit to FDA a premarket 
notification, before marketing the device, which contains information 
about the cord blood processing system and storage container they 
intend to market.

II. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because classification of this device into class II 
will relieve manufacturers of the cost of complying with the premarket 
approval requirements of section 515 of the act (21 U.S.C. 360e), and 
will not constitute a potential barrier to small competitors that may 
wish to enter the market in the future, the agency certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $122 million, using the most current (2005) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, FDA has concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive order and, consequently, a federalism summary 
impact statement is not required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act (PRA) of 1995 is not required. Elsewhere in 
this issue of the Federal Register, FDA is publishing a notice 
announcing the availability of the guidance document entitled ``Class 
II Special Controls Guidance Document: Cord Blood Processing System and 
Storage Container.'' FDA concludes that the special controls guidance 
document contains information collection provisions that are subject to 
review by the OMB under the PRA and that have been approved by OMB in 
accordance with the PRA under the regulations governing premarket 
notification submissions (21 CFR part 807, subpart E; OMB Control No. 
0910-0120).

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Biosafe SA for the classification of the Sepax 
Cell Separation System and single use kits into class II (special 
controls), dated November 1, 2006.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add subpart K, consisting of Sec.  864.9900, to read as follows:

Subpart K--Products Used In Establishments That Manufacture Human 
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)


Sec.  864.9900  Cord blood processing system and storage container.

    (a) Identification. A cord blood processing system and storage 
container is a device intended for use in the processing and the 
storage of cord blood. This device is a functionally closed processing 
system that includes containers, other soft goods, and a centrifugation 
system for cord blood concentration, and a final container for the 
cryopreservation and the storage of a cord blood product.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Cord Blood Processing System and 
Storage Container.'' For the availability of this guidance document, 
see Sec.  864.1(d).

    Dated: January 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1566 Filed 1-31-07; 8:45 am]
BILLING CODE 4160-01-S