MEDICAL DEVICE GOOD MANUFACTURING PRACTICE REGULATIONS

ICR 198808-0910-003

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
109571
Migrated
ICR Details
0910-0073 198808-0910-003
Historical Active 198506-0910-003
HHS/FDA
MEDICAL DEVICE GOOD MANUFACTURING PRACTICE REGULATIONS
Revision of a currently approved collection   No
Regular
Approved without change 10/07/1988
Retrieve Notice of Action (NOA) 08/04/1988
  Inventory as of this Action Requested Previously Approved
10/31/1991 10/31/1991 08/31/1988
7,172 0 7,589
201,930 0 235,204
0 0 0

THE RECORDS REQUIRED BY THE GMP REGULATION ARE AN INTEGRAL PART OF AN EFFECTIVE QUALITY ASSURANCE PROGRAM FOR THE MANUFACTURE OF DEVICES AND AN ESSENTIAL MECHANISM BY WHICH MANUFACTURERS MAINTAIN CONTROL OVER THEIR PROCESS. IN ORDER TO CONSISTENTLY PRODUCE DEVICES CONFORMING TO ESTABLISHED SPECIFICATIONS, CONTROLS MUST BE IN PLACE. PROTECTION OF THE PUBLIC HEALTH DEPENDS UPON THE INFORMATION PROVIDED TO BOTH

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 7,172 7,589 0 0 -417 0
Annual Time Burden (Hours) 201,930 235,204 0 0 -33,274 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.
08/04/1988


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