Medical Device Reporting

OMB Control No: 0910-0437	ICR Reference No: 202412-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202303-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Reporting
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,657,936	0
Time Burden (Hours)	547,263	0
Cost Burden (Dollars)	18,710	0

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Abstract: This ICR collects information from medical device manufacturers, importers, and user facilities that are required to submit electronic and paper medical device reports (MDRs) to the Food and Drug Administration (FDA) and to maintain records, and who may also seek exemption from these requirements. The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under the FD&C Act.

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Authorizing Statute(s): US Code: 21 USC 519(a)(1)(B)(ii) Name of Law: FFDCA    US Code: 21 USC 360i(a)(b)(c) Name of Law: FFDCA

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:
	90 FR 19490	05/08/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 35698	07/29/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

IC Title Form No. Form Name Disclosure; Importer Reporting, Death and Serious Injury Postmarketing Safety Reporting for Combination Products Recordkeeping; MDR Files--803.18 Recordkeeping; MDR Procedures--803.17 Reporting: Special controls: submission of complaint log; 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii) Reporting; Exemptions--803.19 Reporting; Importer Reporting, Death and Serious Injury--803.40 and 803.42 Reporting; Manufacturer Reporting-- 803.50 through 803.53 Reporting; Supplemental Reports--803.56 Reporting; User Facility Annual Reporting--803.33; FDA Form 3419 Form FDA 3419 User Facility Annual Report Form Reporting; User Facility Reporting-- 803.30 and 803.32 Reporting; Voluntary Malfunction Summary Reporting Program

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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	3,657,936	0	0	0	1,527,443	2,130,493
Annual Time Burden (Hours)	547,263	0	0	0	323,806	223,457
Annual Cost Burden (Dollars)	18,710	0	0	0	18,710	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: Since the last extension of this information collection, approved in 2021, we have updated the supporting statement to include an approved revision (2022) which reflects reporting requirements for certain Human Immunodeficiency Virus (HIV) serological diagnostic and supplemental tests (at 21 CFR 866.3956) and for HIV nucleic acid tests (NATs) diagnostic and supplemental tests (at 21 CFR 866.3957). Additionally, we have included burden attributable to provisions set forth in 21 CFR part 4 subpart B, as approved in March 2023 (via nonsubstantive change request), which were previously accounted for in OMB control number 0910-0834 (now discontinued) and are included in the burden estimates above. We also adjusted the Average Burden per Response for “Exemptions—803.19” and “Importer Reporting, Death and Serious Injury--803.40 and 803.42” from 0.1 hour to 1 hour to correct an error introduced in a previous request for extension of this information collection. These adjustments have resulted in an overall increase of 1,527,443 total responses, and a corresponding increase of 323,806 total burden hours. We are revising this information collection to add the FDA guidance entitled “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” which is intended to help manufacturers better understand and use the VMSR Program. The guidance does not affect the burden estimates.

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Annual Cost to Federal Government: $9,415,486

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.     Yes

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

Agency Contact: Amber Sanford 301 796-8867 [email protected]

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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: 07/30/2025

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