MEDICAL DEVICE GOOD MANUFACTURING PRACTICE REGULATIONS

ICR 198506-0910-003

OMB: 0910-0073

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
109570
Migrated
ICR Details
0910-0073 198506-0910-003
Historical Active 198204-0910-004
HHS/FDA
MEDICAL DEVICE GOOD MANUFACTURING PRACTICE REGULATIONS
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 08/12/1985
Retrieve Notice of Action (NOA) 06/14/1985
  Inventory as of this Action Requested Previously Approved
08/31/1988 08/31/1988
7,589 0 0
235,204 0 0
0 0 0

QUALITY ASSURANCE. QUALITY CONTROL. THE RECORDS REQUIRED BY THE GMP REGULATION ARE AN INTEGRAL PART OF AN EFFECTIVE QUALITY ASSURANCE PROGRAM FOR THE MANUFACTURE OF DEVICES, AND ESSENTIAL MECHNISM BY WHIC FIRMS MAINTAIN CONTROL OVER THEIR PROCESSES. PROTECTION OF THE PUBLIC HEALTH DEPENDS UPON INFORMATION PROVIDED TO BOTH FDA AND INDUSTRY BY G RECORDS. TWO REQUIREMENTS PREVIOUSLY CLEARED UNDER 0910-0195 ARE INCLUDED IN THIS REQUEST.

None
None


No

1
IC Title Form No. Form Name
MEDICAL DEVICE GOOD MANUFACTURING PRACTICE REGULATIONS

  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 7,589 0 0 0 7,589 0
Annual Time Burden (Hours) 235,204 0 0 0 235,204 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.
06/14/1985


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