Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paper...
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register
concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with reports of removals and corrections for medical and radiation emitting products
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regulated by FDA's Center for Devices and Radiological Health (CDRH).
DATES:
Either electronic or written comments on the collection of information must be submitted by October 30, 2026.
ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 30, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal:www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to
www.regulations.gov
will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on
www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions:
All submissions received must include the Docket No. FDA-2026-N-9349 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections.” Received comments, those filed in a timely manner (see
ADDRESSES
), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
www.regulations.gov
or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted onwww.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:
www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket:
For access to the docket to read background documents or the electronic and written/paper comments received, go to
www.regulations.gov
and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Amber Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
Federal Register
concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Medical Devices; Reports of Corrections and Removals—21 CFR Part 806
OMB Control Number 0910-0359—Extension
This information collection supports implementation of provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 360i(g)) requiring device manufacturers and importers to report promptly to FDA certain actions concerning device corrections and removals and to maintain associated records. Applicable regulations are found in
21 CFR part 806
and set forth definitions, prescribe format and required content elements for reporting, and identify actions that are exempt from the reporting requirements. The information collected is used by FDA to identify marketed devices that have serious problems and to ensure that defective devices are removed from the market. The
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information also helps ensure that FDA has current and complete information regarding these corrections and removals to determine whether recall action is adequate.
Reports of corrections and removals may be submitted to FDA by mail, email, or using FDA's Electronic Submission Software (eSubmitter). To assist respondents with submitting reports of corrections or removals, we developed Form FDA 5072, “Device Correction/Removal Report for Industry,” a fillable PDF. Reports created using eSubmitter are transmitted to CDRH through FDA's Electronic Submission Gateway (ESG). Instructions for the completing Form FDA 5072 are provided in pop-up text boxes that appear over each data field. We expect that use of the fillable form will expedite processing of the reports of corrections or removals submitted to FDA.
FDA estimates the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden
21 CFR; IC activity
Form
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours 1
Total
operating &
maintenance
costs
Electronic process setup
463
1
463
3.08
1,426
$23,150
806; device product corrections or removals
FDA Form 5072: “Device Correction/Removal Report for Industry”
925
1
925
10
9,250
4.102; combination product corrections or removals (including sharing information with other constituent part applicants under 4.103)
20
1
20
10
200
Total
1,408
10,876
23,150
1
Figures rounded.
For respondents who submit corrections and removals using the ESG, the operating and maintenance costs associated with this information collection are approximately $50 per year to purchase a digital verification certificate (certificate must be valid for 1 to 3 years). This burden may be reduced if the respondent has already purchased a verification certificate for other electronic submissions to FDA.
Table 2—Estimated Annual Recordkeeping Burden
21 CFR; IC activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours 1
806.20; device product corrections and removals
110
1
110
10
1,100
4.105; device-led combination products 1
279
1
279
.5 (45 minutes)
140
Total
389
1,240
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2
Figures rounded.
Our estimated burden for this information collection reflects an overall decrease of 833 hours, with a corresponding decrease of 162 total annual responses and an increase of 170 total annual records. We attribute this adjustment to a decrease in the number of device correction and removal reports received over the last few years, which has reduced our reporting burden estimate from 1,033 to 925 respondents under 21 CFR part 806. This decrease in reporting burden is partially offset by an increase in recordkeeping burden, driven by a revised estimate of records per recordkeeper for device-led combination products under 21 CFR 4.105 and a modest increase in the number of device correction and removal recordkeepers. The estimated Operating and Maintenance Costs associated with electronic process setup has decreased by $2,700 as a result of fewer respondents expected to purchase a digital verification certificate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
Use this for formal legal and research references to the published document.
91 FR 55859
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections,” thefederalregister.org (August 31, 2026), https://thefederalregister.org/documents/2026-17675/agency-information-collection-activities-proposed-collection-comment-request-medical-devices-reports-of-removals-and-cor.
www.regulations.gov
21 CFR 10.20
www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf