Medical Device Labeling Requirements

Forms and Documents

Document Name	Status
83-C_0633 condom labeling recommendations into 0485.docx Justification for No Material/Nonsubstantive Change	2023-08-04
0485 Medical Device Labeling to add UDI 2023 SSA.docx Supporting Statement A	2023-02-26

IC Document Collections

IC ID	Document Title	Status
261474	Specific Labeling for Certain Devices - Natural Rubber Latex Condoms Other-Guidance	New
258774	Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	Unchanged
258139	Labeling requirements for UDI	Unchanged
255349	OTC Hearing Aids Final Rule - New Requirements Other-Agency Guidance	Unchanged
255348	OTC Hearing Aids Final Rule - One Time Burden	Unchanged

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 202308-0910-004
Status: Active	Previous ICR Reference No: 202301-0910-017
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Requirements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/08/2023
	Date Received in OIRA: 08/08/2023
Terms of Clearance: Upon approval the agency will discontinue the collection of information currently approved under OMB control number 0910-0633.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	03/31/2026	03/31/2026
Responses	318,781	0	318,776
Time Burden (Hours)	420,627	0	420,567
Cost Burden (Dollars)	10,100,000	0	10,100,000

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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 360i(f) Name of Law: Unique Device Identification
  

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:
	87 FR 51989	08/24/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 9524	02/14/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Labeling requirements for UDI
OTC Hearing Aids Final Rule - New Requirements
OTC Hearing Aids Final Rule - One Time Burden
Specific Labeling for Certain Devices - Natural Rubber Latex Condoms

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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	318,781	318,776	0	0	5	0
Annual Time Burden (Hours)	420,627	420,567	0	0	60	0
Annual Cost Burden (Dollars)	10,100,000	10,100,000	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: No

Burden Reduction Due to:

Short Statement: For operational efficiency, we are requesting to consolidate burden we attribute to labeling recommendations found in the guidance document, “Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 - Class II Special Controls Guidance for Industry and FDA Staff,” (December 2008) currently approved in control number 0910-0633.

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Annual Cost to Federal Government: $2,633,260

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? No

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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: 08/08/2023

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