[Federal Register Volume 70, Number 46 (Thursday, March 10, 2005)]
[Proposed Rules]
[Pages 11887-11893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4758]
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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 from Class III to Class II of Automated Blood Cell
Separator Device Operating by Centrifugal Separation Principle
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify from class III to class II (special controls) the automated
blood
[[Page 11888]]
cell separator device operating on a centrifugal separation principle
and intended for the routine collection of blood and blood components.
This proposed rule would also modify the special control for the device
with the same intended use but operating on a filtration separation
principle. The reclassification is being proposed on FDA's own
initiative under procedures set forth in FDA regulations and based on
information provided to FDA. This action is being taken under the
Federal Food, Drug, and Cosmetic Act (the act), as amended by the
Medical Device Amendments of 1976 (the 1976 amendments), the Safe
Medical Devices Act of 1990 (the SMDA), and the Food and Drug
Administration Modernization Act of 1997 (FDAMA). The agency proposes
this reclassification because special controls, in addition to general
controls, are capable of providing reasonable assurance of the safety
and effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is publishing a notice of availability of a draft
guidance document entitled ``Class II Special Controls Guidance
Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle,'' which will serve as
the special control if this proposal becomes final.
DATES: Submit written or electronic comments by June 8, 2005. See
section XVI of this document for the proposed effective date of a final
rule based on this document.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0017, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: [email protected]. Include Docket No. 2005N-
0017 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the Comments
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kathleen E. Swisher, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background (Regulatory Authorities)
The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public
Law 105-115), 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 class I (general controls), class II (special controls),
and class III (premarket approval).
Under the 1976 amendments, class II devices were defined as those
devices for which there is insufficient information to show that
general controls themselves will assure safety and effectiveness, but
for which there is sufficient information to establish ``performance
standards'' to provide such assurance. The SMDA revised the definition
of class II devices to include those devices for which there is
insufficient information to show that general controls themselves will
assure safety and effectiveness, but for which there is sufficient
information to establish special controls to provide such assurance.
Special controls may include performance standards, postmarket
surveillance, patient registries, development and dissemination of
guidelines, recommendations, and any other appropriate actions the
agency deems necessary (section 513(a)(1)(B) of the act). The SMDA also
directs FDA to revise the classification of such preamendments class
III devices into class I or class II or require the device to remain in
class III; and directs FDA to issue a schedule for section 515(b) of
the act (21 U.S.C. 360e(b)) rulemaking within 12 months of publication
of a regulation retaining a device in class III. However, the SMDA does
not prevent FDA from proceeding immediately to section 515(b)
rulemaking on specific devices, in the interest of public health,
independent of the 515(i) process.
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 preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
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) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until: (1) The device is
reclassified into class I or II; (2) FDA issues an order classifying
the device into class I or II in accordance with 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,
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 and 21 CFR part 807 of the
regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act requiring premarket
approval.
Reclassification of classified preamendments devices is governed by
section 513(e) of the act. Section 513(e) of the act provides that FDA
may, by rulemaking, reclassify a device (in a proceeding that parallels
the initial classification proceeding) based upon ``new information.''
The reclassification can be initiated by FDA or by the
[[Page 11889]]
petition of an interested person. The term ``new information,'' as used
in section 513(e) 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'' upon which reclassification under section 513(e) of the
act is based must consist of ``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. For the purpose of reclassification, the valid scientific
evidence upon which the agency 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).)
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.
The 1976 amendments did not immediately subject preamendments devices
classified in class III to the premarket approval process. The act
requires FDA to publish 515(b) regulations directing the submission of
premarket approval applications for preamendments class III devices.
The 515(b) process involves the publication of two Federal Register
notices, the proposed rule and the final rule. The 515(b) proposed rule
announces FDA's intention to call for PMAs, lists the issues to be
addressed in PMA submissions, states a deadline for the receipt of
comments, and affords an opportunity to request reclassification. The
final rule addresses any comments received, repeats the issues to be
addressed in PMA submissions, and sets a deadline for the submission of
premarket approval applications or investigational device exemptions of
not more than 90 days after the date of publication.
In the Federal Register of September 11, 1979 (44 FR 53050), FDA
issued a proposed rule to classify into class III the automated blood
cell separator device intended for routine collection of blood and
blood components. The preamble to the proposed rule to classify the
device included the recommendation of an FDA advisory committee, The
Hematology Device Classification Panel, regarding the classification of
the device.
In the Federal Register of September 12, 1980 (45 FR 60643), FDA
issued a final rule (Sec. 864.9245 (21 CFR 864.9245)) classifying into
class III the automated blood cell separator operating either on a
centrifugal or filtration separation principle intended for routine
collection of blood and blood components.
A. Centrifugal Separation Principle
In the Federal Register of February 19, 1988 (53 FR 5108),\1\ FDA
published a proposed rule to require the filing of a PMA or a notice of
completion of a product development protocol (PDP) for the automated
blood cell separator device based on a centrifugal separation principle
and intended for the routine collection of blood and blood components.
The February 1988 proposed rule summarized the risks and benefits
associated with the use of the automated blood cell separator. FDA also
announced an opportunity for interested persons to request a change in
the classification of the device based on new information.
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\1\ In the Federal Register of April 22, 2003 (68 FR 19766), FDA
issued a withdrawal of certain proposed rules and other proposed
actions; notice of intent to withdraw Hematology and Pathology
Devices; Premarket Approval of the Automated Blood Cell Separator
Intended for Routine Collection of Blood and Blood Components.
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In the Federal Register of May 16, 1988 (53 FR 17227), FDA extended
the comment period of the proposed rule from 60 days to 90 days in
response to a letter from a medical trade association requesting
additional time to submit comments. In response to the February 1988
proposed rule, the agency received 17 letters of comment. New
information in the form of scientific evidence was submitted with
several of the comments to FDA on the automated blood cell separator
operating on the centrifugal separation principle. The majority of the
letters of comment indicated there is sufficient evidence to provide
reasonable assurance of the safety and effectiveness of the automated
blood cell separator operating on the centrifugal separation principle,
and supported reclassifying the device into class II when intended only
for routine collection of blood and blood components. Many of the
comment letters provided scientific information and references in
support of the reclassification. FDA has evaluated the information
submitted and decided that there is valid scientific evidence
supporting a change in classification of the centrifugal-based
automated blood cell separator with the intended use of routine
collection of blood and blood components from class III, requiring
premarket approval, to class II, requiring special controls.
Consistent with the act and regulation, FDA referred the proposed
reclassification to a panel for its recommendation on the requested
change in classification. FDA announced in the Federal Register of
April 18, 1989 (54 FR 15558), that the agency would consult with the
Blood Products Advisory Committee (BPAC) in an open meeting on May 11,
1989 (Ref. 1), regarding the reclassification of the automated blood
cell separator operating on a centrifugal separation principle. BPAC
acts in the capacity of a device classification panel for such matters
as new information regarding a device and its classification. FDA
requested that BPAC consider the new information and provide its
recommendation as to whether BPAC agreed that the new information was
substantial and supported reclassification. The recommendation of BPAC
is further discussed in section IV of this document.
In accordance with section 513(e) of the act and Sec.
860.130(b)(1) (21 CFR 860.130(b)(1)), based on new information with
respect to the device, FDA, on its own initiative, is proposing to
reclassify the centrifugal-based automated blood cell separator device
from class III to class II (special controls) when the intended use of
the device is for the routine collection of blood and blood components.
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 FDA's Center for
Devices and Radiological Health and are not part of Sec. 864.9245.
[[Page 11890]]
B. Filtration Separation Principle
The automated blood cell separator device operating on a filtration
separation principle and intended for the routine collection of blood
and blood components is a postamendments device originally classified
into class III under section 513(f)(1) of the act. On June 17, 1996,
the Baxter Healthcare Corp. submitted to FDA a petition requesting
reclassification from class III to class II of its AUTOPHERESIS-C
SYSTEM device. The petition contained information in the form of
scientific evidence to provide reasonable assurance of the safety and
effectiveness of the filtration-based AUTOPHERESIS-C SYSTEM device.
Consistent with section 513(f)(3) of the act and 21 CFR 860.134, FDA
referred the petition to the BPAC medical devices panel for its
recommendation on the requested change in classification. At a public
meeting held on September 27, 1996, BPAC unanimously recommended that
the AUTOPHERESIS-C SYSTEM and subsequent membrane-based blood cell
separators substantially equivalent to this device, intended for
routine collection of blood and blood components, be reclassified from
class III to class II. The panel believed that class II with the
special controls of a periodic report filed annually for a minimum of 3
years with emphasis on adverse reactions would provide reasonable
assurance of the safety and effectiveness of the device.
FDA published a notice of BPAC's recommendation in the Federal
Register of May 29, 2001 (66 FR 29149). In this notice, FDA issued its
tentative findings on BPAC's recommendation and requested from the
public comments on BPAC's recommendation. The comment period closed
August 13, 2001. After receiving no comments on BPAC's recommendation
for reclassification or our tentative findings on BPAC's
recommendation, FDA approved the reclassification petition by order in
the form of a letter to the petitioner.
In the Federal Register of February 28, 2003 (68 FR 9530), FDA
published a final rule announcing the decision to reclassify from class
III to class II the filtration-based automated blood cell separator
device intended for routine collection of blood and blood components
(the February 2003 final rule). In addition to general controls of the
act, the February 2003 final rule also provided for special controls
applicable to the filtration-based devices in order to provide
reasonable assurance of the safety and effectiveness of the device.
In this rule, we are proposing to change the special control listed
in the February 2003 final rule for the filtration-based device. We
propose the special control to be a draft guidance entitled ``Class II
Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Separation Principle.''
This draft guidance, if finalized, 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.
III. Device Description
Current Sec. 864.9245 provides a brief description of the
automated blood cell separator device operating on either a centrifugal
separation principle or a filtration separation principle. The current
section describes the automated blood cell separator as a device that
automatically withdraws whole blood from a donor, separates the blood
into components (red blood cells, white blood cells, plasma, and
platelets), retains one or more of the components, and returns the
remainder of the blood to the donor. The components obtained are
transfused or used for further manufacturing to prepare blood products
for administration. The separation bowls of centrifugal blood cell
separators may be reusable or disposable.
The current section classifies the centrifugal-based automated
blood cell separator into class III (premarket approval). This proposed
rule reclassification from class III to class II (special controls)
applies to the automated blood cell separator device that operates by
centrifugal separation principle and is intended for the routine
collection of blood and blood components for transfusion or further
manufacturing use. The proposed rule removes in the identification of
the automated blood cell separator the words that were in parentheses--
red blood cells, white blood cells, plasma, and platelets.
IV. Recommendation of the Panel
At a public meeting held on May 11, 1989, the BPAC panel considered
the new information presented in the letters of comment and unanimously
recommended that the centrifugal-based automated blood cell separator
be reclassified from class III (premarket approval) to class II
(performance standards; now included in special controls). The panel
believed that class II with performance standards (now included in
special controls) would provide reasonable assurance of the safety and
effectiveness of the automated blood cell separator and that there is
sufficient information publicly available to establish a performance
standard (special control) to assure safety and effectiveness of the
device.
We believe another device classification panel recommendation is
not necessary since, prior to the SMDA, a panel recommended
classification into class II. If a panel recommended that a device be
reclassified from class III into class II under the 1976 definition of
class II, which included only performance standards as a class II
control, then the panel's recommendation for class II status would not
change if special controls are required that would include performance
standards, among other controls. Under the SMDA, FDA may establish
special controls, including performance standards, postmarket
surveillance, patient registries, guidelines, and other appropriate
actions it believes necessary to provide reasonable assurance of the
safety and effectiveness of the device.
V. Summary of Reasons for Recommendation (Reclassification)
The panel believes that the centrifugal-based automated blood cell
separator device should be reclassified into class II because
performance standards (special controls), in addition to general
controls, provide reasonable assurance of the safety and effectiveness
of the device, and there is sufficient information to establish special
controls to provide such assurance.
VI. Risks to Health
In the February 1988 proposed rule, FDA outlined its proposed
findings regarding potential risks associated with the automated blood
cell separator intended for routine collection of blood and blood
components. FDA's proposed findings showed the following: A major risk
to health of donors is that the process of removing blood, handling the
blood outside the body, and returning the blood to the donor's
circulatory system could injure the cellular components of the blood
and activate the body's complement system (a series of enzymatic
proteins capable, when activated, of destroying intact cells). Another
potential donor reaction is fever, due to a breakdown of granulocytes
(leukocytes containing granules) during the pump cycle of the automated
blood cell separator.
Also, if the automated blood cell separator fails to perform
satisfactorily, the donor may have one or more of the following adverse
reactions: (1) Shock resulting from blood loss; (2) toxic reaction to
high levels of anticoagulants,
[[Page 11891]]
such as citrate, that the automated blood cell separator adds to the
blood as it is collected and before the blood is returned to the donor;
(3) stress reaction due to the removal or loss of blood; (4) thrombosis
due to activation of clotting factors in the blood by surfaces within
the automated blood cell separator; or (5) sepsis and fever due to
bacterial contamination of the blood returned to the donor.
Lastly, an unexpected or an undetected leak in the blood handling
system of the device presents risks of infections to donors, patients,
and operators of the device. The device presents a risk of electrical
shock or injury to operators and donors if the device has an electrical
malfunction. If the automated blood cell separator fails to perform
satisfactorily, the blood or blood components collected from a donor
may not be suitable for use because of cellular damage to blood or
blood components during the collection process. One form of cellular
damage is red blood cell hemolysis (destruction of the cell membrane
accompanied by the release of hemoglobin).
Public comments received in response to the proposed rule indicated
that the occurrence of these risks was very low, referred to ample
evidence showing the safety and effectiveness of the automated blood
cell separator, and supported reclassification of the device into class
II.
Presently, FDA has identified the following risks associated with
apheresis blood donation and processing: (1) The potential loss of
blood due to leaks; (2) thrombosis due to activation of factors by
foreign surfaces; (3) toxic reaction to citrate anticoagulant; (4)
damage to red blood cells, activation of complement, and denaturation
of proteins; (5) potential for sepsis and fever due to bacterial
contamination of the donor's blood returned to the donor; (6)
infectious disease risk to the donor or to the operator due to leaks;
(7) electrical shock hazard; (8) donor stress reaction due to removal
or loss of blood; (9) air embolism; (10) hemolysis; and (11) reservoir
rupture.
In addition to the potential risks of the centrifugal-based
automated blood cell separator, there is sufficient information about
the benefits of the device. Extensive experience with the device
indicates that the centrifugal-based automated blood cell separator is
safe and effective for the intended use of routine collection of blood
and blood components.
VII. Summary of Data Upon Which the Recommendation (Reclassification)
is Based
In response to the February 1988 rule proposing to place the device
in class III, we received 17 letters of comment from manufacturers and
the blood banking community (Ref. 1 at 103). These commenters included
such organizations as the Health Industry Manufacturers Association and
the American Association of Blood Banks (Ref. 1 at 104). The comments
received indicated the risk to benefit ratio is low. In proposing this
reclassification, we considered these industry comments and the history
for over 30 years of safe use of the centrifugal-based automated blood
cell separator device.
VIII. FDA's Tentative Findings
FDA believes that the special controls discussed in section IX of
this document are capable of providing reasonable assurance of the
safety and effectiveness of the automated blood cell separator device
operating on a centrifugal separation principle with regard to the
identified risks to health of this device. Based on FDA's evaluation of
the additional information received in the letters of comment, as well
as the 1989 BPAC panel recommendation and the safety record of the
device in actual use, the agency has reconsidered the February 1988
proposed rule, and believes that the centrifugal-based automated blood
cell separator device should be classified into class II (special
controls). FDA, through an agency-wide action of proposed rule
withdrawals (April 22, 2003, 68 FR 19766), announced its intention to
withdraw the February 1988 proposed rule. Now, FDA is proposing to
amend the device regulations by reclassifying from class III to class
II (special controls guidance) the centrifugal-based automated blood
cell separator device intended for the routine collection of blood and
blood components. FDA is also changing the special control for the
automated blood cell separator device using the filtration separation
principle for the routine collection of blood and blood components. The
same special control guidance will apply to the filtration and
centrifugal-based devices when these devices are used for the routine
collection of blood and blood components.
IX. Special Controls
Based on available information and in addition to general controls,
FDA believes that the FDA 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,'' can provide reasonable assurance of the safety and
effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of this draft guidance
document.
For currently marketed products not approved under the PMA process,
the draft guidance document recommends that the manufacturer file with
FDA for three consecutive years an annual report on the anniversary
date of the final rule for reclassification or on the anniversary date
of 510(k) clearance. Any subsequent change to the device requiring the
submission of a premarket notification in accordance with section
510(k) of the act should be included in the annual report. A
manufacturer of a device that is determined to be substantially
equivalent to the automated blood cell separator device operating by
centrifugal or filtration separation principles intended for routine
collection of blood and blood components, also would be required to
comply with the same general and special controls. The firm would need
to show that its device meets the recommendations of the guidance or in
some other way provides equivalent assurances of safety and
effectiveness.
The draft guidance document (special control) recommends that each
annual report include, at a minimum, the following information:
A summary of anticipated and unanticipated donor adverse
device events that have occurred and that are not required to be
reported by manufacturers under Medical Device Reporting (MDR).\2\ We
recommend summarizing and reporting donor adverse device events such as
those required under Sec. 606.160(b)(1)(iii) (21 CFR
606.160(b)(1)(iii))\3\\,\\4\ to be recorded and maintained by the
facility\5\ using
[[Page 11892]]
the device for the routine collection of blood and blood components.
Under 21 CFR 803.50(b)(2), manufacturers are responsible for conducting
an investigation of each event and evaluating the cause of the event.
Therefore, this information should be available to the manufacturer to
summarize and provide to FDA in the annual report. We emphasize that
safety information submitted to FDA is not to be considered an
admission of causation or liability (October 27, 1994, 59 FR 54046 at
54051).
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\2\ 21 CFR 803.1(a) -- ``* * * device user facilities,
importers, and manufacturers, as defined in Sec. 803.3, must report
deaths and serious injuries to which a device has or may have caused
or contributed * * * .''
\3\ Section 606.160(b) -- ``Records shall be maintained that
include, but are not limited to, the following when applicable: * *
* (1)(iii) Donor adverse reaction complaints and reports, including
results of all investigations and followup.''
\4\ In a separate proposed rulemaking (Safety Reporting
Requirements for Human Drug and Biological Products; Proposed Rule
(68 FR 12405, March 14, 2003)), FDA has proposed amending 21 CFR
606.170 to require the investigation and recording by blood
establishments of any complaint of a serious adverse reaction
related to the collection or transfusion of blood or blood
components.
\5\ ``Facility'' means any area used for the collection,
processing, compatibility testing, storage or distribution of blood
and blood components (21 CFR 606.3(h)). Also, applicable is ``device
user facility'' under Sec. 803.3(f), meaning ``a hospital,
ambulatory surgical facility, nursing home, outpatient diagnostic
facility, or outpatient treatment facility * * *.'' (Note: The donor
becomes a patient when he or she experiences and is treated for an
adverse event contributed to or caused by the medical device.)
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Any subsequent change to the device requiring the
submission of a premarket notification in accordance with section
510(k) of the act.\6\
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\6\ For assistance see the guidance document entitled ``Deciding
When to Submit a 510(k) for a Change to an Existing Device,''
January 1997, at http://www.fda.gov/cdrh.
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Any subsequent change to the preamendments class III
device requiring a 30-day notice in accordance with 21 CFR 814.39(f).
The reporting of adverse device events summarized in an annual
report will alert FDA to trends or clusters of events that might be a
safety issue otherwise unreported under the MDR regulation. Adverse
reactions contributed to or caused by an apheresis blood donation
device, such as operator infection or injury; equipment failures,
including software, hardware, and disposable item failures; thrombosis;
sepsis; and shock resulting from blood loss, may be reportable under
MDR. The annual report need not include MDR reports.
X. References
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Blood Products Advisory Committee Meeting Transcript, May 11,
1989.
XI. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
reclassification 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.
XII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed 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,
the agency tentatively concludes that the proposed rule does not
contain policies that have federalism implications as defined in the
Executive order and, consequently, a federalism summary impact
statement has not been prepared.
XIII. Analysis of Impacts
FDA has examined the impacts of this proposed 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 proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
order and so is not subject to review under the Executive order.
Under the Regulatory Flexibility Act, if a rule has a significant
economic impact on a substantial number of small entities, an agency
must consider alternatives that would minimize the economic impact of
the rule on small entities. Reclassification of this device from class
III to class II will relieve manufacturers of the cost of complying
with the premarket approval requirements of section 515 of the act, and
may permit small potential competitors to enter the marketplace by
lowering their costs. Although the proposed rule special control
guidance document recommends that manufacturers of these devices file
with FDA an annual report for three consecutive years, this is less
burdensome than the current premarket approval requirements including
the submission of periodic reports (21 CFR 814.84).
The agency, therefore, certifies that this proposed rule, if
finalized, will not have a significant economic impact on a substantial
number of small entities, and no further analysis is required under the
Regulatory Flexibility Act. In addition, the Unfunded Mandates Reform
Act does not require FDA to prepare a statement of costs and benefits
for this proposed rule because the proposed rule will not impose costs
of $100 million or more on State, local, and tribal governments in the
aggregate, or the private sector, in any one year (adjusted annually
for inflation).
XIV. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) is not required.
XV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
XVI. Proposed Effective Date
The agency is proposing that any final rule that may issue based
upon this proposed fule become effective 30 days after its date of
publication in the Federal Register.
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, it is
proposed that 21 CFR part 864 be 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:
[[Page 11893]]
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: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4758 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S