[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Pages 41410-41411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17080]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 Separation Principle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
13, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0594. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 Separation Principle (OMB 
Control Number 0910-0594)--Extension

    Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), 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.
    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.  
    Collecting or transfusing facilities, and manufacturers have 
certain responsibilities under the 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

[[Page 41411]]

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.
    In the Federal Register of February 15, 2012 (77 FR 8879), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                      Table 1--Estimated Annual Reporting Burden\1\
                                                                                         Number of
                         Reporting activity                             Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
Annual Reporting...................................................               4                1                4                5               20
\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 manufactures of 
automated blood cell separator devices. We estimate that the 
manufacturers will spend approximately 5 hours 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, 21 CFR part 803).

    Dated: July 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17080 Filed 7-12-12; 8:45 am]