Medical Device Labeling Regulations

ICR 200201-0910-009

OMB: 0910-0485

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
6186
Migrated
ICR Details
0910-0485 200201-0910-009
Historical Active
HHS/FDA
Medical Device Labeling Regulations
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/21/2002
Retrieve Notice of Action (NOA) 01/25/2002
Approved consistent with clarifications in FDA memo of 3-7-02 attached. This collection has been in place without OMB approval and hence has been in violation of the Paperwork Reduction Act. This shall be noted in the annual Information Collection Budget.
  Inventory as of this Action Requested Previously Approved
03/31/2005 03/31/2005
2,320,385 0 0
3,191,305 0 0
0 0 0

Manufacturers, packers, and distributors of medical devices are required to assure that the labeling of the device includes adequate directions for use according to whether the device is intended for use by health care professionals or lay persons.

None
None


No

1
IC Title Form No. Form Name
Medical Device Labeling 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 2,320,385 0 0 2,320,385 0 0
Annual Time Burden (Hours) 3,191,305 0 0 3,191,305 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
01/25/2002


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