Medical Device Labeling Regulations

ICR 201808-0910-008

OMB: 0910-0485

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-09-12
IC Document Collections
IC ID
Document
Title
Status
6187
Removed
232983
New
232982
New
214614
Removed
214613
Removed
214612
Removed
214611
Removed
214610
Removed
214609
Removed
214608
Removed
214607
Removed
214606
Removed
214605
Removed
214604
Removed
214602
Removed
214601
Removed
214599
Removed
214598
Removed
214597
Removed
214596
Removed
214595
Removed
214594
Removed
214593
Removed
214592
Removed
214591
Removed
214590
Removed
214589
Removed
214588
Removed
214587
Removed
214586
Removed
214585
Removed
ICR Details
0910-0485 201808-0910-008
Active 201501-0910-005
HHS/FDA CDRH
Medical Device Labeling Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 10/15/2018
Retrieve Notice of Action (NOA) 09/13/2018
  Inventory as of this Action Requested Previously Approved
10/31/2021 36 Months From Approved 10/31/2018
81,908,682 0 60,871,112
12,289,240 0 10,690,449
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

  83 FR 7728 02/22/2018
83 FR 44884 09/04/2018
Yes

2
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)
Adequate directions for use--801.5
Statement of identify--801.61
Declaration of net quantity of contents--801.62
Processing, labeling, or repacking; non-sterile devices--801.150(e)
Hearing aids, opportunity to review User Instructional Brochure--801.421(b)
Hearing aids, availability of User Instructional Brochure--801.421(c)
User labeling for menstrual tampons--801.430(d)
Menstrual tampons, ranges of absorbency--801.430(e)(2)
User labeling for latex condoms--801.435(b), (c), and (h)
Labeling for IVDs--809.10(a) and (b)
Labeling for general purpose laboratory reagents--809.10(d)(1)
Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f)
Labeling of sunlamp products--1040.20(d)
Labeling for analyte specific reagents--809.10(e)
Advertising and promotional materials for ASRs--809.30(d)
Medical Device Labeling Regulations; Recordkeeping
Processing, labeling, or repacking agreement--801.150(a)(2)
Hearing aid records--801.421(d)
Menstrual tampons, sampling plan for measuring absorbency--801.430(f)
Medical Device Labeling Regulations; Third-Party Disclosure
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f)
Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1)
Dentures; information regarding temporary and emergency use--801.405(c)
Prescription device labeling--801.109
Labeling requirements for hearing aids--801.420(c)(1)
Technical Data for hearing aids--801.420(c)(4)
Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c)
Manufacturer, packer, or distributor information--801.1
Retail exemption for prescription devices--801.110

  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 81,908,682 60,871,112 0 -60,871,112 81,908,682 0
Annual Time Burden (Hours) 12,289,240 10,690,449 0 -10,690,449 12,289,240 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
The estimated annual hourly burden, formerly estimated as 10,678,247 hours (2,240,929 recordkeeping and 8,437,318 third-party disclosure) has increased by 1,610,359 hours (1,022,621 recordkeeping and 587,738 third-party disclosure) to a total estimated annual hourly burden of 12,288,606 hours (3,263,550 recordkeeping and 9,025,056 third-party disclosure. The increase is due to adjustments reflecting updated data. We note that ROCIS database is inconsistent with the number of burden hours in the previous Supporting Statement (approved 9/22/2015, supporting statement states 10,678,247 hours, ROCIS states 10,690,449 hours). Upon submitting this Supporting Statement, we will correct the error in ROCIS.

$2,573,850
No
    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.
09/13/2018


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