[Federal Register Volume 70, Number 46 (Thursday, March 10, 2005)]
[Notices]
[Pages 11990-11991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4764]



[[Page 11990]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0019]


Draft Guidance for Industry and Food and Drug Administration 
Staff on Class II Special Controls Guidance Document: Automated Blood 
Cell Separator Device Operating by Centrifugal or Filtration Separation 
Principle; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Class II Special Controls 
Guidance Document: Automated Blood Cell Separator Device Operating by 
Centrifugal or Filtration Separation Principle'' dated January 2005. 
The draft guidance document serves as the special control to support 
the reclassification from class III to class II of the automated blood 
cell separator device operating on a centrifugal or filtration 
separation principle intended for the routine collection of blood and 
blood components. This draft guidance document describes a means by 
which the automated blood cell separator device operating by 
centrifugal or filtration separation principle may comply with the 
requirement of special controls for class II devices. Elsewhere in this 
issue of the Federal Register, FDA is publishing a proposed rule to 
reclassify these device types into class II (special controls).

DATES: Submit written or electronic comments on the draft guidance by 
June 8, 2005 to ensure their adequate consideration in preparation of 
the final guidance. General comments on agency guidance documents are 
welcome at any time. Submit written comments on the information 
collection burden by May 9, 2005.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling the Center for Biologics Evaluation and Research Voice 
Information System at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

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

    FDA is announcing the availability of a draft document entitled 
``Class II Special Controls Guidance Document: Automated Blood Cell 
Separator Device Operating by Centrifugal or Filtration Separation 
Principle'' dated January 2005. This special control guidance 
identifies the relevant classification regulation, which provides a 
description of the applicable automated blood cell separator. In 
addition, other sections of this special control guidance list the 
risks to health identified by FDA and describe measures that, if 
followed by manufacturers and combined with general controls, will 
ordinarily address the risks associated with these automated blood cell 
separators.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirement of the applicable 
statutes and regulations.

II. Comments

    The draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance. Submit written or electronic comments to ensure adequate 
consideration in preparation of the final guidance. 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 the brackets in the heading 
of this document. A copy of the draft guidance and received comments 
are available for public examination in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act of 1995

    The draft guidance document contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval 
from OMB for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on the following topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Draft Guidance for Industry--Class II Special Controls Guidance 
Document: Automated Blood Cell Separator Device Operating by 
Centrifugal or Filtration Separation Principle

    Under the Safe Medical Devices Act of 1990 (Public Law 101-629, 104 
Stat. 4511), 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

[[Page 11991]]

safety and effectiveness of the device. This draft guidance document 
serves as the special control to support the reclassification from 
class III to class II of the automated blood cell separator device 
operating on a centrifugal separation principle intended for the 
routine collection of blood and blood components; and, serves as the 
special control for the filtration-based device with the same intended 
use reclassified as class II in the Federal Register of February 28, 
2003 (68 FR 9530).
    For currently marketed products not approved under the premarket 
approval (PMA) process, the manufacturer should file with FDA for 3 
consecutive years an annual report on the anniversary date of the 
device reclassification from Class III to Class II or, on the 
anniversary date of the 510(k) clearance. Any subsequent change to the 
device requiring the submission of a premarket notification in 
accordance with section 510(k) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360) should be included in the annual report. 
Also, a manufacturer of a device determined to be substantially 
equivalent to the centrifugal or filtration-based automated blood cell 
separator device intended for the routine collection of blood and blood 
components, should comply with the same general and special controls.
    The annual report should include, at a minimum, a summary of 
anticipated and unanticipated donor adverse device events that have 
occurred, such as those required under (Sec.  606.160(b)(1)(iii) 21 CFR 
606.160(b)(1)(iii))\1\ to be recorded and maintained by the facility 
using the device to collect blood and blood components, and that might 
not be reported by manufacturers under Medical Device Reporting (MDR). 
Also, equipment failures, including software, hardware, and disposable 
item failures' should be reported. 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.
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    \1\ 21 CFR 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, inlcuding 
results of all investigations and followup.''
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    Reclassification of this device from class III to class II for the 
intended use of routine collection of blood and blood components will 
relieve manufacturers of the burden of complying with the premarket 
approval requirements of section 515 of the act (21 U.S.C. 360e), and 
may permit small potential competitors to enter the marketplace by 
reducing the burden. Although the special control guidance document 
recommends that manufacturers of these devices file with FDA an annual 
report for three consecutive years, this would be less burdensome than 
the current postapproval requirements under part 814, subpart E (21 CFR 
part 814, subpart E), including the submission of periodic reports 
under Sec.  814.84.
    Collecting or transfusing facilities, and manufacturers have 
certain responsibilities under the CFR. Among others, collecting or 
transfusing facilities are required to maintain records of any reports 
of complaints of adverse reactions (Sec.  606.170), while the 
manufacturer is responsible for conducting an investigation of each 
event that is reasonably known to the manufacturer and evaluating the 
cause of the event Sec.  803.50(b)(2) (21 CFR 803.50(b)(2)). In the 
draft guidance document, we recommend that manufacturers include in 
their three annual reports a summary of adverse reactions maintained by 
the collecting or transfusing facility or similar reports of adverse 
events collected in addition to those required under the MDR 
regulation.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      Annual Frequency per      Total Annual
                                            Number of Respondents           Response              Responses         Hours per Response      Total Hours
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Annual Report                                                    4                        1                   4                        5              20
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on FDA records, there are approximately four manufacturers of 
automated blood cell separator devices. We estimate that the 
manufacturers will spend approximately 5 hours preparing and submitting 
the annual report. The total annual burden of this collection of 
information is estimated at approximately 20 hours.
    Other burden hours required for proposed 21 CFR 864.9245 are 
already reported and approved under OMB control number 0910-0120 
(premarket notification submission 510(k), 21 CFR part 807, subpart E), 
and OMB control number 0910-0437 (MDR). Currently, manufacturers of 
medical devices are required to submit to FDA individual adverse event 
reports of death, serious injury, and malfunctions (Sec. Sec.  803.50 
and 803.53). The manufacturer is responsible for conducting an 
investigation of each event and evaluating the cause of the event 
(Sec.  803.50(b)(2)).
    The reporting recommended in the special control guidance document 
broadens the information to be reported by manufacturers to FDA. 
Although the manufacturer's reporting burden is increased, the 
collection burden remains unchanged. We are recommending that the 
manufacturer submit annually, for 3 consecutive years, a summary of all 
adverse events, including those reported under part 803. The Mandatory 
MedWatch Reporting Form 3500A: Codes Manual, contains a comprehensive 
list of adverse events associated with device use, including most of 
those events that we recommend summarizing in the annual report.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4764 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S