Submission of Validation Data for Reprocessed Single-Use Devices

ICR 200307-0910-002

OMB: 0910-0514

Federal Form Document

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ICR Details
0910-0514 200307-0910-002
Historical Active
Submission of Validation Data for Reprocessed Single-Use Devices
New collection (Request for a new OMB Control Number)   No
Emergency 08/08/2003
Approved with change 08/18/2003
Retrieve Notice of Action (NOA) 07/11/2003
This paperwork is approved on an emergency basis under the following conditions: 1) In the future, FDA will not publish guidance documents with information collection provisions that have immediate effect without first obtaining OMB clearance. 2) FDA will revise the guidance document to contain the PRA mandated disclosure statement including the collection's OMB number, expiration date and expected burden.
  Inventory as of this Action Requested Previously Approved
01/31/2004 01/31/2004
234 0 0
28,000 0 0
0 0 0

The Medical Device User Fee and Modernization Act of 2002 requires manufactures of processed single use devices to submit to FDA validation data to show that the devices will remain safe after reprocessing in accordance with the device labeling. New manufacturers will need to submit the data immediately. Manufacturers with cleared devices will need to do so within 9 months of FDA notification. Manufacturers previously exempt will have 15 months to submit the data.



IC Title Form No. Form Name
Submission of Validation Data for Reprocessed Single-Use Devices

  Total Approved 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 234 0 0 234 0 0
Annual Time Burden (Hours) 28,000 0 0 28,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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.

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