Medical Devices: Medical Device Reporting, Certification

ICR 200004-0910-004

OMB: 0910-0059

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0059 200004-0910-004
Historical Active 199909-0910-004
HHS/FDA
Medical Devices: Medical Device Reporting, Certification
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 04/10/2000
Retrieve Notice of Action (NOA) 04/10/2000
  Inventory as of this Action Requested Previously Approved
04/30/2000 04/30/2000 06/30/2000
21,600 0 21,600
195,210 0 195,210
0 0 0

This regulation requires medical device user facilities, manufacturers, and distributors to report deaths, serious injuries, and certain malfunctions related to medical devices. This final rule amends reporting requirements for device manufacturers and distributors re: The certification language and instructions approved under Information Collection 0910-0059.

None
None


No

1
IC Title Form No. Form Name
Medical Devices: Medical Device Reporting, Certification FDA-3417

  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 21,600 21,600 0 0 0 0
Annual Time Burden (Hours) 195,210 195,210 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.
04/10/2000


© 2024 OMB.report | Privacy Policy