Medical Device Recall Authority

ICR 200212-0910-001

OMB: 0910-0432

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6105
Migrated
ICR Details
0910-0432 200212-0910-001
Historical Active 199911-0910-002
HHS/FDA
Medical Device Recall Authority
Extension without change of a currently approved collection   No
Regular
Approved without change 01/22/2003
Retrieve Notice of Action (NOA) 12/19/2002
  Inventory as of this Action Requested Previously Approved
02/28/2006 02/28/2006 01/31/2003
2 0 2
1,082 0 1,082
0 0 0

This regulation (21 CFR part 810) establish procedures FDA will follow in exercising its medical device recall authority. Title 21 CFR Part 810 promulgated under the statutory mandate of section 518(e) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 301 et. seq.) gives FDA the authority to issue an order requiring the appropriate person; including manufacturers, importers, distributors, and retailers of a device, to immediately cease distribution of such device, and to immediately notify health professionals and device user facilities of the order, and to instruct such professionals.....

None
None


No

1
IC Title Form No. Form Name
Medical Device Recall Authority

  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 2 2 0 0 0 0
Annual Time Burden (Hours) 1,082 1,082 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
12/19/2002


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