[Federal Register: November 30, 2007 (Volume 72, Number 230)]
[Rules and Regulations]
[Page 67640-67644]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no07-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 864
[Docket No. 2005N-0017]
Medical Devices; Hematology and Pathology Devices:
Reclassification of Automated Blood Cell Separator Device Operating by
Centrifugal Separation Principle
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying from
class III to class II the automated blood cell separator device
operating by centrifugal separation principle and intended for the
routine collection of blood and blood components. FDA is taking this
action on its own initiative based on new information. Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of a guidance document that will serve as the special controls for this
device, as well as the special controls for the device with the same
intended use but operating on a filtration separation principle.
[[Page 67641]]
DATES: This rule is effective December 31, 2007. The reclassification
date is November 30, 2007.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research, Food and Drug Administration (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act (SMDA)
(Public Law 101-629), the Food and Drug Administration Modernization
Act (FDAMA) (Public Law 105-115), and the Medical Device User Fee and
Modernization Act (Public Law 107-250) established a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the act (21 U.S.C. 360c) established three categories
(classes) of devices, depending on the regulatory controls needed to
provide reasonable assurance of their safety and effectiveness. The
three categories of devices are as follows:
Class I (general controls),
Class II (special controls), and
Class III (premarket approval).
Under the 1976 amendments, class II devices were defined as devices
for which there was insufficient information to show that general
controls themselves would provide reasonable assurance of safety and
effectiveness, but for which there was sufficient information to
establish performance standards to provide such assurance. SMDA
broadened the definition of class II devices to mean those devices for
which the general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there
is sufficient information to establish special controls to provide such
assurance, including performance standards, post-market surveillance,
patient registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the act).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendment devices, are
classified after FDA:
1. Receives a recommendation from a device classification panel (an
FDA advisory committee);
2. Publishes the panel's recommendation for comment, along with a
proposed regulation classifying the device; and
3. Publishes a final regulation classifying the device.
FDA has classified most preamendments devices under these
procedures.
1. Devices that were not in commercial distribution before May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) (21 U.S.C.
360c(f)) into class III without any FDA rulemaking process. Those
devices remain in class III and require premarket approval unless and
until FDA reclassifies the device into class I or class II.
2. FDA issues an order classifying the device into class I or II in
accordance with new section 513(f)(2) of the act, as amended by FDAMA;
or
3. FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the act (21 U.S.C. 360c(i)), to a
predicate device that does not require premarket approval.
The agency determines whether new devices are substantially
equivalent to previously offered devices by means of premarket
notification procedures in section 510(k) of the act (21 U.S.C. 360(k))
and part 807 of the regulations (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed through premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Section 513(e) of the act governs reclassification of classified
preamendments devices. This section provides that FDA may, by
rulemaking, reclassify a device (in a proceeding that parallels the
initial classification proceeding) based upon ``new information.'' FDA
can initiate a reclassification under section 513(e) or an interested
person may petition FDA to reclassify a preamendments device. The term
``new information,'' as used in section 513(e)(1) of the act, includes
information developed as a result of a reevaluation of the data before
the agency when the device was originally classified, as well as
information not presented, not available, or not developed at that
time. (See, e.g., Holland Rantos v. United States Department of Health,
Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978);
Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966)).
Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951). Regardless of
whether data before the agency are past or new data, the ``new
information'' to support reclassification under section 513(e)(1) of
the act must be ``valid scientific evidence,'' as defined in section
513(a)(3) of the act and 21 CFR 860.7(c)(2). (See, e.g., General
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc.
v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)).
FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which FDA relies must be publicly available. Publicly
available information excludes trade secret and/or confidential
commercial information, e.g., the contents of a pending PMA. (See
section 520(c) of the act (21 U.S.C. 360j(c)).
Section 510(m) of the act (21 U.S.C. 360(m)) provides that FDA
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 believes that an automated
blood cell separator device operating by centrifugal separation
principle should not be exempt from premarket notification under
section 510(m) of the act because premarket notification is necessary
to provide reasonable assurance of the safety and effectiveness of the
device.
II. Regulatory History of the Device
The automated blood cell separator device operating by centrifugal
separation principle intended for the routine collection of blood and
blood components is a preamendments device classified into class III.
In the Federal Register of March 10, 2005 (70 FR 11887), based on
new information with respect to the device, FDA proposed, on its own
initiative, to reclassify from class III to class II the automated
blood cell separator device
[[Page 67642]]
operating by centrifugal separation principle, when the intended use of
the device is for the routine collection of blood and blood components.
Interested persons were invited to comment on the proposed rule by June
8, 2005. FDA received one comment on the proposed rule and draft
guidance and that comment was considered as the rule and guidance were
finalized.
Also, FDA is correcting a regulatory citation in the proposed rule
of March 10, 2005 (70 FR 11887), on page 11892, in the first column,
starting in the second line; ``21 CFR 803.50(b)(2)'' is corrected to
read ``21 CFR 803.50(b)(3))''.
FDA also identified the draft guidance entitled ``Guidance for
Industry and FDA Staff: Class II Special Controls Guidance Document:
Automated Blood Cell Separator Device Operating by Centrifugal or
Filtration Separation Principle'' as the proposed special controls
capable of providing reasonable assurance of safety and effectiveness
for these devices.
III. Summary of Final Rule
Under section 513(e) of the act and Sec. 860.130 (21 CFR 860.130),
based on new information and on its own initiative, FDA is
reclassifying from class III to class II (special controls) the
automated blood cell separator device operating by centrifugal
separation principle and intended for the routine collection of blood
and blood components. The special controls in conjunction with general
controls will provide reasonable assurance of the safety and
effectiveness of the device. For all other uses, including therapeutic
apheresis, the device remains in its current classification as class
III. All therapeutic apheresis (blood cell separator) devices are
regulated by the Center for Devices and Radiological Health and are not
part of Sec. 864.9245 (21 CFR 864.9245).
The automated blood cell separator device operating by centrifugal
separation principle is assigned the generic name, automated blood cell
separator. It is identified as a device that automatically withdraws
whole blood from a donor, separates the blood into components, retains
one or more components, and returns the remainder of the blood to the
donor. This final rule removes reference in Sec. 864.9245, to the
words that were in parentheses, specifically, red blood cells, white
blood cells, plasma, and platelets. The components obtained are
transfused or used for further manufacturing. The separation bowls of
centrifugal blood cell separators may be reusable or disposable, as
specified by the device manufacturer.
Also in this rule, we are removing from Sec. 864.9245(b), the list
of special controls for the class II automated blood cell separator
device operating by filtration separation principle and intended for
the routine collection of blood and blood components. The special
controls guidance entitled ``Guidance for Industry and FDA Staff: Class
II Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Principle'' will provide
the special controls for both filtration- and centrifugal-based
automated blood cell separator devices intended for the routine
collection of blood and blood components. The availability of this
guidance is announced elsewhere in this issue of the Federal Register.
The special controls guidance document recommends that the
manufacturer file with FDA for 3 consecutive years an annual report on
the anniversary date of the final rule for reclassification or on the
anniversary date of 510(k) clearance. Each annual report should
include, at a minimum, the following information:
A summary of anticipated and unanticipated donor adverse
events that have occurred and that are not required to be reported by
manufacturers under part 803 (21 CFR part 803) Medical Device Reporting
(MDR);
Any subsequent change to the device requiring the
submission of a premarket notification in accordance with section
510(k) of the act;
Any subsequent change to the preamendments class III
device requiring a 30-day notice in accordance with Sec. 814.39(f) (21
CFR 814.39(f)).
For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device and, therefore, the type of device is
not exempt from premarket notification requirements. Prior to marketing
the device, persons must submit to FDA a premarket notification
containing information about the automated blood cell separator device
they intend to market. Following the effective date of this final rule,
any firm submitting a 510(k) premarket notification for an automated
blood cell separator device operating by filtration or centrifugal
separation principle and intended for the routine collection of blood
and blood components will need to address the issues covered in the
special controls guidance. However, the firm need only show that its
device meets the recommendations of the guidance or in some other way
provides equivalent assurance of safety and effectiveness.
IV. Analysis of Comments on the Proposed Rule and FDA's Response
FDA received one comment on the proposed rule. The comment
supported the reclassification of the automated blood cell separator
device operating by centrifugal separation principle and intended for
the routine collection of blood and blood components. In addition, the
comment provided specific questions about the reporting requirements in
the special controls guidance document and asked FDA to clarify these
reporting requirements.
We first provide a general response to the comment and then respond
to the questions submitted in the comment. To make it easier to
identify the questions provided in the comment and our responses, the
word ``Comment,'' in parentheses, will appear before the description of
the question, and the word ``Response,'' in parentheses, will appear
before our response. We numbered the comments to distinguish the
questions.
When the device is reclassified, all manufacturers of currently
marketed automated blood cell separators operating by centrifugal
separation principle not approved under the premarket approval process
should file annual reports for 3 consecutive years on the anniversary
date of reclassification of the device from class III to class II, or
on the anniversary date of the 510(k) clearance. Within the 3-year
reporting period, any subsequent change to the device requiring a
510(k) should be included in the annual report. The criteria for
reporting changes to the device and its labeling under 510(k) are
delineated in FDA's guidance ``Deciding When to Submit a 510(k) for a
Change to an Existing Device,'' January 10, 1997.
However, manufacturers of automated blood cell separator devices
operating by filtration separation principle that were classified into
class II (68 FR 9530, February 28, 2003) were subject to the special
controls of Sec. 864.9245 issued in 2003, requiring 3 consecutive
years of submitting annual reports. These devices are not required to
initiate another cycle of annual reports as a result of the change of
special controls for those devices codified by this rule.
Under Sec. Sec. 606.160(b)(1)(iii) and 606.170 (21 CFR
606.160(b)(1)(iii) and 606.170), the facility using the device to
collect blood and blood components is required to keep records of donor
adverse reaction complaints and reports, including results of all
investigations
[[Page 67643]]
and followup. Under Sec. 803.50(b)(3), manufacturers are responsible
for conducting an investigation of each event and evaluating the cause
of the event. The special controls would have the manufacturer
summarize this information and submit it to FDA in the annual report.
Specific questions submitted in the comment and FDA's responses:
(Comment 1) Do you intend to request 3-year annual reporting only
for the initial 510(k) clearance for the automated blood cell separator
device?
(Response) Yes. The 3-year annual reporting described in the
special controls guidance document recommends annual reporting only for
the initial 510(k) clearance. Any subsequent change to the device
within this 3-year reporting period requiring the submission of a
premarket notification in accordance with section 510(k) of the act
should be included in the annual report. However, the submission of
this 510(k) information concerning a change to the device would not
restart the 3-year reporting period.
(Comment 2) Is it correct that for a device originally approved
under the PMA process, then switched to a 510(k), annual reporting
would not be required?
(Response) Yes, this is correct, if an automated blood cell
separator device intended for the routine collection of blood and blood
components was originally approved under the PMA process.
(Comment 3) Does this reporting requirement apply to all automated
blood cell separator devices operating by centrifugal or filtration
separation principle intended for the routine collection of blood and
blood components regardless of when the original clearance was granted?
Would any preamendments devices be ``grandfathered'' in so that the
reporting would not be required?
(Response) The reporting recommended in the special controls
guidance applies to currently marketed products not approved under the
PMA process. The 3-year annual reporting for these products should
begin on the anniversary date of the device reclassification from class
III to class II, or, on the anniversary date of 510(k) clearance.
In this rulemaking, we are reclassifying the automated blood cell
separator device operating by centrifugal separation principle from
class III to class II. Therefore, the reclassification date from class
III to class II for the automated blood cell separator device operating
by centrifugal separation principle and intended for the routine
collection of blood and blood components is the date of publication in
the Federal Register of this final rule (see DATES). The
reclassification date from class III to class II for the automated
blood cell separator device operating by filtration separation
principle and intended for the routine collection of blood and blood
components is February 28, 2003.
Devices in commercial distribution before May 28, 1976, are also
referred to as preamendments devices. On September 12, 1980 (45 FR
60643), FDA issued a final rule classifying these preamendment
automated blood cell separator devices as class III (premarket
approval). The 1976 amendments did not immediately subject preamendment
devices classified in class III to the preamendment process. In the
regulation (Sec. 864.9245), FDA did not set a deadline for the
submission of premarket approval applications for the device. That
regulation is amended in this rulemaking to reclassify the device from
class III to class II. Therefore, preamendments devices are subject to
this rulemaking, and the special controls guidance document as of the
anniversary date of device reclassification from class III to class II.
V. FDA's Conclusion
Therefore, under section 513 of the act, FDA is adopting the
summary of reasons for the Panel's recommendation and the summary of
data upon which the Panel's recommendation is based (70 FR 11887 at
11890). FDA is also adopting the risks to public health stated in the
proposed rule (70 FR 11887 at 11891). Furthermore, FDA is issuing a
final rule that revises Sec. 864.9245, thereby, reclassifying the
generic type of device, automated blood cell separator operated by
centrifugal separation principle and intended for the routine
collection of blood and blood components from class III into class II.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and 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. The reclassification of automated blood cell
separator devices from class III to class II will relieve manufacturers
of the cost of complying with the premarket approval requirements in
section 515 of the act. Although the special controls guidance document
recommends that manufacturers of these devices file with FDA an annual
report for 3 consecutive years, this is less burdensome than the
current premarket approval requirements, including the submission of
periodic reports (21 CFR 814.84). By eliminating the need for premarket
approval applications, reclassification will reduce regulatory costs
with respect to these devices, impose no significant economic impact on
any small entities, and may permit small potential competitors to enter
the marketplace by lowering their costs. The agency therefore certifies
that this final rule will not have a significant 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 $127 million, using the most current (2006) 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.
VII. 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.
VIII. 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
[[Page 67644]]
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency 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.
IX. 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 of 1995 (PRA) is not required. FDA concludes
that the special controls guidance document contains information
collection provisions that are subject to review and clearance by OMB
under the PRA. 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:
Automated Blood Cell Separator Device Operating by Centrifugal of
Filtration Separation Principle.'' The notice contains an analysis of
the paperwork burden for the guidance.
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. Section 864.9245 is revised to read as follows:
Sec. 864.9245 Automated blood cell separator.
(a) Identification. An automated blood cell separator is a device
that uses a centrifugal or filtration separation principle to
automatically withdraw whole blood from a donor, separate the whole
blood into blood components, collect one or more of the blood
components, and return to the donor the remainder of the whole blood
and blood components. The automated blood cell separator device is
intended for routine collection of blood and blood components for
transfusion or further manufacturing use.
(b) Classification. Class II (special controls). The special
control for this device is a guidance for industry and FDA staff
entitled ``Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Separation
Principle.''
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23285 Filed 11-29-07; 8:45 am]
BILLING CODE 4160-01-S