Document ID: FDA-2012-N-0115-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug
Administration Staff—Class II Special Controls Guidance Document:
Automated Blood Cell Separator Device Operating by Centrifugal or
Filtration Principle
Posted Date: 2015-01-29T05:00Z

[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4927-4928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01626]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0115]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry and Food and Drug Administration 
Staff--Class II Special Controls Guidance Document: Automated Blood 
Cell Separator Device Operating by Centrifugal or Filtration Principle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
concerning class II special controls for an automated blood cell 
separator device operating by centrifugal or filtration separation 
principle.

DATES: Submit either electronic or written comments on the collection 
of information by March 30, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Springs, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(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, including 
each proposed extension of an existing 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 these 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.

Guidance for Industry and FDA Staff--Class II Special Controls Guidance 
Document: Automated Blood Cell Separator Device Operating by 
Centrifugal or Filtration Separation Principle (OMB Control Number 
0910-0594)--Extension

    Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), FDA 
may

[[Page 4928]]

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. The special control guidance 
serves 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 as well as the special control for the automated blood 
cell separator device operating on a filtration separation principle 
intended for the routine collection of blood and blood components 
reclassified as class II (Sec.  864.9245 (21 CFR 864.9245)).
    For currently marketed products not approved under the premarket 
approval 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) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360) clearance. Any subsequent change to 
the device requiring the submission of a premarket notification in 
accordance with section 510(k) of the FD&C Act 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 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 adverse events that have occurred and 
that are not required to be reported by manufacturers under Medical 
Device Reporting (MDR) (part 803 (21 CFR part 803)). 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.
    Reclassification of this device from class III to class II for the 
intended use of routine collection of blood and blood components 
relieves manufacturers of the burden of complying with the premarket 
approval requirements of section 515 of the FD&C 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 recommends 
that manufacturers of these devices file with FDA an annual report for 
3 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 Federal regulations. For example, collecting or 
transfusing facilities are required to maintain records of any reports 
of complaints of adverse reactions (21 CFR 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)). In addition, manufacturers of 
medical devices are required to submit to FDA individual adverse event 
reports of death, serious injury, and malfunctions (Sec.  803.50).
    In the special control guidance document, FDA recommends 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. The MedWatch medical device 
reporting code instructions (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106737.htm) contains a 
comprehensive list of adverse events associated with device use, 
including most of those events that we recommend summarizing in the 
annual report.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                         Reporting activity                             Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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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. The estimated average burden 
per response is based on the time that the manufacturers will spend 
preparing and submitting the annual report.
    Other burden hours required for Sec.  864.9245 are reported and 
approved under OMB control number 0910-0120 (premarket notification 
submission 501(k), 21 CFR part 807, subpart E), and OMB control number 
0910-0437 (MDR, part 803).

    Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01626 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P