Medical Device Recall Authority

ICR 200902-0910-003

OMB: 0910-0432

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-02-13
IC Document Collections
IC ID
Document
Title
Status
6106
Modified
ICR Details
0910-0432 200902-0910-003
Historical Active 200512-0910-001
HHS/FDA
Medical Device Recall Authority
Extension without change of a currently approved collection   No
Regular
Approved without change 04/10/2009
Retrieve Notice of Action (NOA) 02/27/2009
  Inventory as of this Action Requested Previously Approved
04/30/2012 36 Months From Approved 04/30/2009
2 0 2
1,090 0 1,082
0 0 0

This regulation (21 CFR part 810) establish procedures FDA will follow in exercising its medical device recall authority. 21 CFR Part 810 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, and to notify health professionals and device user facilities of the order, and to instruct them to cease use of such device, if FDA finds there is a reasonable probability the device intended for human use would cause serious adverse health consequences or death.

US Code: 21 USC 360h Name of Law: null
  
None

Not associated with rulemaking

  73 FR 77719 12/19/2008
74 FR 8799 02/26/2009
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) 1,090 1,082 0 0 8 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$186,000
No
No
Uncollected
Uncollected
No
Uncollected
Denver Presley 3018271462

  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.
02/27/2009


© 2024 OMB.report | Privacy Policy