Medical Devices; Reports of Corrections and Removals

ICR 202008-0910-010

OMB: 0910-0359

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0359 202008-0910-010
Active 201706-0910-008
Medical Devices; Reports of Corrections and Removals
Revision of a currently approved collection   No
Approved with change 10/09/2020
Retrieve Notice of Action (NOA) 08/31/2020
  Inventory as of this Action Requested Previously Approved
10/31/2023 36 Months From Approved 10/31/2020
1,686 0 1,033
13,115 0 14,408
25,850 0 30,660

The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal.

US Code: 21 USC 360i(g) Name of Law: FFDCA; Records and Reports on Devices

Not associated with rulemaking

  85 FR 10168 02/21/2020
85 FR 51451 08/20/2020

IC Title Form No. Form Name
Device corrections and removals
Combination product reports and recordkeeping
eSubmitter participants

  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 1,686 1,033 0 0 653 0
Annual Time Burden (Hours) 13,115 14,408 0 0 -1,293 0
Annual Cost Burden (Dollars) 25,850 30,660 0 0 -4,810 0
The information collection reflects revision and adjustment. We have revised the collection to include reporting and recordkeeping resulting from provisions associated with combination products established by rulemaking (0910-AF82). At the same time, upon review we noted calculation errors in our last submission. Cumulatively these changes result in 653 additional responses, 1,293 fewer burden hours, and a reduction of $4,810 in costs.

Domini Bean 301 796-5733 [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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