Registration & listing of devices: REPORTING

Electronic Submission of Medical Device Registration and Listing

Documents and Forms

Document Name Document Type
Form FDA 3673 Registration & listing of devices: REPORTING Form
FDA 3673 FDA 3673 0625_Form FDA 3673 Screen shots.pdf Form

Information Collection (IC) Details

IC Title:	Registration & listing of devices: REPORTING	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 807

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	0625_Form FDA 3673 Screen shots.pdf		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: 95,781	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	95,781	-23,013	118,794
Annual IC Time Burden (Hours)	56,544	-14,759	71,303
Annual IC Cost Burden (Dollars)	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.