Medical Device Labeling Regulations

ICR 201501-0910-005

OMB: 0910-0485

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-06-18
IC Document Collections
IC ID
Document
Title
Status
6187
Modified
214614
New
214613
New
214612
New
214611
New
214610
New
214609
New
214608
New
214607
New
214606
New
214605
New
214604
New
214602
New
214601
New
214599
New
214598
New
214597
New
214596
New
214595
New
214594
New
214593
New
214592
New
214591
New
214590
New
214589
New
214588
New
214587
New
214586
New
214585
New
ICR Details
0910-0485 201501-0910-005
Historical Active 201108-0910-006
HHS/FDA CDRH
Medical Device Labeling Regulations
Revision of a currently approved collection   No
Regular
Approved with change 09/22/2015
Retrieve Notice of Action (NOA) 01/30/2015
OMB notes and commends the significant revision to estimates in this submission.
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved 09/30/2015
60,871,112 0 2,432,136
10,690,449 0 3,784,684
0 0 0

This ICR collects information from manufacturers, importers, and distributors of medical devices to disclose to health professionals and consumers specific information about themselves or their devices on the label or labeling of their devices. The primary users of the information disclosed on the label or in the labeling of devices are the health professionals who use or prescribe the device or the lay consumers who use the device. The labeling should contain sufficient information for these persons to use the device safely and effectively. FDA may use the information to determine whether there is reasonable assurance of the safety and effectiveness of the device for its intended use.

US Code: 21 USC 352 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 44782 08/01/2014
80 FR 4928 01/29/2015
No

29
IC Title Form No. Form Name
Latex condoms; justification for the application of testing data to the variation of the tested product--801.435(g)
Liquid ophthalmic preparation labeling--800.10(b)(2)
Manufacturer, packer, or distributor information--801.1
Adequate directions for use--801.5
Statement of identify--801.61
Retail exemption for prescription devices--801.110
Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1)
Processing, labeling, or repacking agreement--801.150(a)(2)
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f)
Hearing aid records--801.421(d)
Menstrual tampons, sampling plan for measuring absorbency--801.430(f)
Declaration of net quantity of contents--801.62
Prescription device labeling--801.109
Processing, labeling, or repacking; non-sterile devices--801.150(e)
Dentures; information regarding temporary and emergency use--801.405(c)
Hearing aids, opportunity to review User Instructional Brochure--801.421(b)
User labeling for menstrual tampons--801.430(d)
Labeling for IVDs--809.10(a) and (b)
Labeling for general purpose laboratory reagents--809.10(d)(1)
Labeling for analyte specific reagents--809.10(e)
Advertising and promotional materials for ASRs--809.30(d)
User labeling for latex condoms--801.435(b), (c), and (h)
Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f)
Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c)
Labeling requirements for hearing aids--801.420(c)(1)
Technical Data for hearing aids--801.420(c)(4)
Hearing aids, availability of User Instructional Brochure--801.421(c)
Menstrual tampons, ranges of absorbency--801.430(e)(2)
Labeling of sunlamp products--1040.20(d)

  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 60,871,112 2,432,136 0 58,438,976 0 0
Annual Time Burden (Hours) 10,690,449 3,784,684 0 6,905,765 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The estimated annual hourly burden, formerly estimated as 3,784,684 hours (422,207 recordkeeping and 3,362,477 third-party disclosure) has increased by 6,888,735 hours (1,806,694 recordkeeping and 5,082,041 third-party disclosure) to a total estimated annual hourly burden of 10,673,419 hours (2,236,101 recordkeeping and 8,437,318 third-party disclosure). The increase is due to adjustments reflecting updated data and to corrections made at Agency discretion to increase the accuracy of our estimate.

$2,834,870
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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.
01/30/2015


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