[Federal Register: February 1, 2007 (Volume 72, Number 21)]
[Rules and Regulations]
[Page 4637-4638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe07-6]
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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