Initial Registration & Listing

Electronic Submission of Medical Device Registration and Listing

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0625 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3673 Initial Registration & Listing Form
FDA 3673 FDA 3673 Form FDA 3673 Screen shots.doc Form
FDA 3673 FDA 3673 Form FDA 3673 Screen shots.doc Form

Information Collection (IC) Details

IC Title:	Initial Registration & Listing	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3,467	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	Previously Approved
Annual Number of Responses for this IC	3,467	3,467
Annual IC Time Burden (Hours)	3,467	3,467
Annual IC Cost Burden (Dollars)	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.