Medical Device Labeling Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
273539	Guidance Recommendations re. Scientific Information on Unapproved Use Disclosures		New
261474	Specific Labeling for Certain Devices - Natural Rubber Latex Condoms		Unchanged
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		Unchanged
255348	OTC Hearing Aids Final Rule - One Time Burden		Unchanged

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 202501-0910-003
Status: Active	Previous ICR Reference No: 202308-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/29/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/07/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2028	36 Months From Approved	03/31/2026
Responses	363,934	0	318,781
Time Burden (Hours)	440,280	0	420,627
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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 73031	10/24/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 1146	01/07/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Guidance Recommendations re. Scientific Information on Unapproved Use Disclosures
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

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	363,934	318,781	0	45,153	0	0
Annual Time Burden (Hours)	440,280	420,627	0	19,653	0	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: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The information collection includes a program change pertaining to disclosure burden we attribute to agency guidance. We have added 45,153 responses and 19,653.3 hours annually to the information collection.

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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: 01/07/2025

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