Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

ICR 202106-0910-010

OMB: 0910-0594

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-07-07
IC Document Collections
IC ID
Document
Title
Status
43606 Modified
ICR Details
0910-0594 202106-0910-010
Received in OIRA 201807-0910-003
HHS/FDA CBER
Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Extension without change of a currently approved collection   No
Regular 07/08/2021
  Requested Previously Approved
36 Months From Approved 08/31/2021
3 3
15 15
0 0

In the special control guidance document, FDA recommends that manufacturers include in their three annual reports a summary of adverse reactions that are 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/DeviceRegulationand Guidance/Guidance Documents/ucm106737.htm) contains a comprehensive list of adverse events associated with device use, including most of those events that FDA recommends summarizing in the annual report. 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.

PL: Pub.L. 101 - 629 104 Name of Law: Safe Medical Devices Act of 1990
   US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  86 FR 10108 02/18/2021
86 FR 30958 06/10/2021
No

1
IC Title Form No. Form Name
Annual Report

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 3 3 0 0 0 0
Annual Time Burden (Hours) 15 15 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$225
No
    Yes
    No
No
No
No
No
Ila Mizrachi 301 796-7726 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
07/08/2021


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