MEDICAL DEVICE REPORTING

ICR 198905-0910-004

OMB: 0910-0201

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
165478 Migrated
ICR Details
0910-0201 198905-0910-004
Historical Active 198808-0910-004
HHS/FDA
MEDICAL DEVICE REPORTING
No material or nonsubstantive change to a currently approved collection   No
Emergency 05/02/1989
Approved with change 05/02/1989
Retrieve Notice of Action (NOA) 05/02/1989
  Inventory as of this Action Requested Previously Approved
05/31/1990 05/31/1990 05/31/1990
17,598 0 17,598
71,112 0 71,112
0 0 0

THIS REGULATION REQUIRES A MANUFACTURER OR IMPORTER OF MEDICAL DEVICES TO REPORT TO FDA WHEN THEY POSSESS INFORMATION SUGGESTING A DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, OR HAS MALFUNCTIONED AND IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. IMPORTERS ARE REQUIRED TO ESTABLISH AND MAINTAIN FILE OF REPORTS AND RECORDS.

None
None


No

1
IC Title Form No. Form Name
MEDICAL DEVICE REPORTING FDA 3322

  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 17,598 17,598 0 0 0 0
Annual Time Burden (Hours) 71,112 71,112 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.
05/02/1989


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