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Annual Registration
Electronic Submission of Medical Device Registration and Listing
OMB: 0910-0625
IC ID: 184861
OMB.report
HHS/FDA
OMB 0910-0625
ICR 201904-0910-010
IC 184861
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0625 can be found here:
2022-06-29 - Extension without change of a currently approved collection
2021-05-25 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
Form FDA 3673
Annual Registration
Form
FDA 3673 FDA 3673
Form FDA 3673 Screen shots.doc
Form
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Annual Registration
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 807.22
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form
FDA 3673
FDA 3673
Form FDA 3673 Screen shots.doc
Yes
Yes
Fillable Fileable Signable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
23,403
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
99 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
23,403
0
0
3,048
0
20,355
Annual IC Time Burden (Hours)
11,702
0
0
-3,564
0
15,266
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.