Medical Devices; Humanitarian Use Devices

Forms and Documents

Document Name	Status
0910-0332 Supporting Statement_2025.docx Supporting Statement A	2025-12-19

IC Document Collections

IC ID	Document Title	Status
5922	Medical Devices; Humanitarian Use Devices - Reporting	Modified
275855	Humanitarian Use Devices; Notification of emergency use--814.124(a)	New
275454	Medical Devices; Humanitarian Use Devices - Recordkeeping	New
258995	Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)	Modified
255790	Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements Other-Guidance; Humanitarian Device Exemption (HDE) Program - Gu	Modified

ICR Details

OMB Control No: 0910-0332	ICR Reference No: 202505-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202303-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Humanitarian Use Devices
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/19/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	323	0
Time Burden (Hours)	22,584	0
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports implementation of statutory and regulatory requirements governing humanitarian use devices (HUDs) required by the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are manufacturers and/or sponsors of these devices.

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Authorizing Statute(s): US Code: 21 USC 360(e)
   US Code: 21 USC 360(d)
  

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:
	90 FR 38151	08/07/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 57067	12/09/2025
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
Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)
Humanitarian Use Devices; Notification of emergency use--814.124(a)
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Medical Devices; Humanitarian Use Devices - Recordkeeping
Medical Devices; Humanitarian Use Devices - Reporting

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ICR Summary of Burden

	Total Request	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	323	0	0	0	-63	386
Annual Time Burden (Hours)	22,584	0	0	0	-321	22,905
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: No

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall decrease of 321 hours and a corresponding decrease of 63 responses. The total hour burden for this information collection is estimated to be 22,584 hours.

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Annual Cost to Federal Government: $9,781,342

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.     Yes

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: 12/19/2025

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