Medical Device Labeling Regulations

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0485--Labeling--SS--06-17-15_updated.doc	Supporting Statement A	Uploaded 2015-06-18	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6187	Processing, labeling, or repacking agreement--801.150(a)(2)		Modified
214614	Labeling of sunlamp products--1040.20(d)		New
214613	Advertising and promotional materials for ASRs--809.30(d)		New
214612	Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f)		New
214611	Labeling for analyte specific reagents--809.10(e)		New
214610	Labeling for general purpose laboratory reagents--809.10(d)(1)		New
214609	Labeling for IVDs--809.10(a) and (b)		New
214608	User labeling for latex condoms--801.435(b), (c), and (h)		New
214607	Menstrual tampons, ranges of absorbency--801.430(e)(2)		New
214606	User labeling for menstrual tampons--801.430(d)		New
214605	Hearing aids, availability of User Instructional Brochure--801.421(c)		New
214604	Hearing aids, opportunity to review User Instructional Brochure--801.421(b)		New
214602	Technical Data for hearing aids--801.420(c)(4)		New
214601	Labeling requirements for hearing aids--801.420(c)(1)		New
214599	Dentures; information regarding temporary and emergency use--801.405(c)		New
214598	Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1)		New
214597	Processing, labeling, or repacking; non-sterile devices--801.150(e)		New
214596	Retail exemption for prescription devices--801.110		New
214595	Prescription device labeling--801.109		New
214594	Declaration of net quantity of contents--801.62		New
214593	Statement of identify--801.61		New
214592	Adequate directions for use--801.5		New
214591	Manufacturer, packer, or distributor information--801.1		New
214590	Liquid ophthalmic preparation labeling--800.10(b)(2)		New
214589	Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c)		New
214588	Latex condoms; justification for the application of testing data to the variation of the tested product--801.435(g)		New
214587	Menstrual tampons, sampling plan for measuring absorbency--801.430(f)		New
214586	Hearing aid records--801.421(d)		New
214585	Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f)		New

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 201501-0910-005
Status: Historical Active	Previous ICR Reference No: 201108-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/22/2015
	Date Received in OIRA: 01/30/2015
Terms of Clearance: OMB notes and commends the significant revision to estimates in this submission.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	09/30/2015
Responses	60,871,112	0	2,432,136
Time Burden (Hours)	10,690,449	0	3,784,684
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 44782	08/01/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 4928	01/29/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 29

table that charts list of burden

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)

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ICR Summary of Burden

table that charts list of burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: 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.

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Annual Cost to Federal Government: $2,834,870

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/30/2015

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