Electronic Submission of Medical Device Registration and Listing

ICR 202104-0910-012

OMB: 0910-0625

Federal Form Document

ICR Details
0910-0625 202104-0910-012
Received in OIRA 201904-0910-010
Electronic Submission of Medical Device Registration and Listing
No material or nonsubstantive change to a currently approved collection   No
Regular 05/25/2021
  Requested Previously Approved
06/30/2022 06/30/2022
192,343 186,230
102,950 93,798
0 0

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.

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

Not associated with rulemaking

  83 FR 62583 12/04/2018
84 FR 20138 05/08/2019

  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

Amber Sanford 301 796-8867 [email protected]


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:
    (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;
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.

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