Electronic Submission of Medical Device Registration and Listing

Forms and Documents

Document Name	Status
Form FDA 3673 FDA 3673 Form	Modified
Form FDA 3673 Registration & listing of devices: REPORTING Form	Modified
0910-0625_Supporting Statement A_2026.docx Supporting Statement A	2026-04-01
0910-0625_Supporting Statement A_2025.docx Supporting Statement A	2025-08-28

IC Document Collections

IC ID	Document Title	Status
203601	Registration & listing of devices: RECORDKEEPING	Modified
202256	Annual Request for Waiver from Electronic Registration & Listing (one time)	Unchanged
202255	Initial Request for Waiver from Electronic Registration & Listing (recurring)	Unchanged
184861	Registration & listing of devices: REPORTING Form	Modified	FDA 3673
184861	Registration & listing of devices: REPORTING Form	Modified

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 202505-0910-006
Status: Active	Previous ICR Reference No: 202206-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Electronic Submission of Medical Device Registration and Listing
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 with change	Conclusion Date: 04/08/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/29/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2029	36 Months From Approved	04/30/2026
Responses	196,777	0	220,775
Time Burden (Hours)	95,292	0	113,832
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver.

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Authorizing Statute(s): US Code: 21 USC 510(j)(2)
   US Code: 21 USC 510(p)
   US Code: 21 USC 510(b)
  

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 26304	06/20/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 42251	08/29/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Annual Request for Waiver from Electronic Registration & Listing (one time)
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Registration & listing of devices: RECORDKEEPING
Registration & listing of devices: REPORTING	FDA 3673	FDA 3673

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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	196,777	220,775	0	0	-23,998	0
Annual Time Burden (Hours)	95,292	113,832	0	0	-18,540	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: No

Burden Reduction Due to:

Short Statement: ROCIS reflects a decrease in burden; however, the amount shown differs from the actual change because burden figures were erroneously entered in ROCIS during the prior renewal, and there were also calculation errors in the supporting statement. The current submission corrects these issues, and the resulting change reflects both the actual burden adjustment and the correction of those prior errors. Under the previous supporting statement, the estimated annual reporting burden was 63,297 hours and the recordkeeping burden was 39,649 hours, for a combined total of 102,946 hours. In the current period, reporting burden is estimated at 55,643 hours and recordkeeping remains 39,649 hours, for a new combined total of 95,292 hours. The estimated burden for the information collection reflects a decrease of 7,654 hours overall. FDA attributes this adjustment in the number of submissions received over the last approval period.

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Annual Cost to Federal Government: $724,544

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: 08/29/2025

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