Medical Device Labeling Regulations

Forms and Documents

Document	Type	Status	Availability
0485_Supporting Statement_2018.doc	Supporting Statement A	Uploaded 2018-09-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6187	Processing, labeling, or repacking agreement--801.150(a)(2)		Removed
232983	Medical Device Labeling Regulations; Third-Party Disclosure		New
232982	Medical Device Labeling Regulations; Recordkeeping		New
214614	Labeling of sunlamp products--1040.20(d)		Removed
214613	Advertising and promotional materials for ASRs--809.30(d)		Removed
214612	Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f)		Removed
214611	Labeling for analyte specific reagents--809.10(e)		Removed
214610	Labeling for general purpose laboratory reagents--809.10(d)(1)		Removed
214609	Labeling for IVDs--809.10(a) and (b)		Removed
214608	User labeling for latex condoms--801.435(b), (c), and (h)		Removed
214607	Menstrual tampons, ranges of absorbency--801.430(e)(2)		Removed
214606	User labeling for menstrual tampons--801.430(d)		Removed
214605	Hearing aids, availability of User Instructional Brochure--801.421(c)		Removed
214604	Hearing aids, opportunity to review User Instructional Brochure--801.421(b)		Removed
214602	Technical Data for hearing aids--801.420(c)(4)		Removed
214601	Labeling requirements for hearing aids--801.420(c)(1)		Removed
214599	Dentures; information regarding temporary and emergency use--801.405(c)		Removed
214598	Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1)		Removed
214597	Processing, labeling, or repacking; non-sterile devices--801.150(e)		Removed
214596	Retail exemption for prescription devices--801.110		Removed
214595	Prescription device labeling--801.109		Removed
214594	Declaration of net quantity of contents--801.62		Removed
214593	Statement of identify--801.61		Removed
214592	Adequate directions for use--801.5		Removed
214591	Manufacturer, packer, or distributor information--801.1		Removed
214590	Liquid ophthalmic preparation labeling--800.10(b)(2)		Removed
214589	Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c)		Removed
214588	Latex condoms; justification for the application of testing data to the variation of the tested product--801.435(g)		Removed
214587	Menstrual tampons, sampling plan for measuring absorbency--801.430(f)		Removed
214586	Hearing aid records--801.421(d)		Removed
214585	Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f)		Removed

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 201808-0910-008
Status: Active	Previous ICR Reference No: 201501-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Regulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/15/2018
	Date Received in OIRA: 09/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	36 Months From Approved	10/31/2018
Responses	81,908,682	0	60,871,112
Time Burden (Hours)	12,289,240	0	10,690,449
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:
	83 FR 7728	02/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 44884	09/04/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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

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ICR Summary 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	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

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 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.

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Annual Cost to Federal Government: $2,573,850

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 09/13/2018

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