Electronic Submission of Medical Device Registration and Listing

Forms and Documents

Document Name	Status
Form FDA 3673 Identification of initial importers by foreign establishments Form	Unchanged
Form FDA 3673 Annual Update of Listing Information Form	Unchanged
Form FDA 3673 Annual Update of Changes to US Agent Information Form	Unchanged
Form FDA 3673 Initial Registration & Listing Form	Unchanged
Form FDA 3673 Annual Registration Form	Unchanged
0625 Change Request to include 0852 GFI MAY 2021.docx Justification for No Material/Nonsubstantive Change	2021-05-24
0625_Supporting Statement_2019.doc Supporting Statement A	2019-05-17

IC Document Collections

IC ID	Document Title	Status
247600	Transfer of 510(k) Notification: Agency GFI Recommendations Other-Agency Guidance	New
203608	Intitial Submittal of Manufacturer Information by Initial Importers (One time)	Unchanged
203607	Identification of other parties that facilitate import by foreign establishments	Unchanged
203606	Identification of initial importers by foreign establishments Form	Unchanged
203605	US Agent Responses to FDA Requests for Information	Unchanged
203604	Annual Registration & Listing when Electronic Filing Waiver granted (recurring)	Unchanged
203603	Initial Registration & Listing when Electronic Filing Waiver Granted (one time)	Unchanged
203602	Labeling & Advertisement Submitted at FDA Request	Unchanged
203601	Creation of electronic system account	Unchanged
203600	Annual Submittal of Manufacturer Information by Initial Importers (recurring)	Unchanged
203599	Other Updates of Registration	Unchanged
202258	Labeling & Advertisements Available for Review	Unchanged
202257	List of Officers, Directors and Partners	Unchanged
202256	Annual Request for Waiver from Electronic Registration & Listing (one time)	Unchanged
202255	Initial Request for Waiver from Electronic Registration & Listing (recurring)	Unchanged
202254	Annual Update of Listing Information Form	Unchanged
202253	Annual Update of Changes to US Agent Information Form	Unchanged
202251	Initial Registration & Listing Form	Unchanged
184861	Annual Registration Form	Unchanged

ICR Details

OMB Control No: 0910-0625	ICR Reference No: 202104-0910-012
Status: Received in OIRA	Previous ICR Reference No: 201904-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Electronic Submission of Medical Device Registration and Listing
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/25/2021

	Requested	Previously Approved
Expiration Date	06/30/2022	06/30/2022
Responses	192,343	186,230
Time Burden (Hours)	102,950	93,798
Cost Burden (Dollars)	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:
	83 FR 62583	12/04/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 20138	05/08/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 19

IC Title	Form No.	Form Name
Annual Registration	FDA 3673	FDA 3673
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Annual Request for Waiver from Electronic Registration & Listing (one time)
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Annual Update of Changes to US Agent Information	FDA 3673	FDA 3673
Annual Update of Listing Information	FDA 3673	FDA 3673
Creation of electronic system account
Identification of initial importers by foreign establishments	FDA 3673	FDA 3673
Identification of other parties that facilitate import by foreign establishments
Initial Registration & Listing	FDA 3673	FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Labeling & Advertisement Submitted at FDA Request
Labeling & Advertisements Available for Review
List of Officers, Directors and Partners
Other Updates of Registration
Transfer of 510(k) Notification: Agency GFI Recommendations
US Agent Responses to FDA Requests for Information

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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	192,343	186,230	0	0	6,113	0
Annual Time Burden (Hours)	102,950	93,798	0	0	9,152	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:

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Annual Cost to Federal Government: $540,610

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: 05/25/2021

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