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 Form FDA 3673 Screen shots.doc Form
FDA 3673 FDA 3673 Form FDA 3673 Screen shots.doc 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, subparts A through D (To search for a specific CFR, visit the Code of Federal Regulations.)

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: 28,496	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	118,794	95,391	23,403
Annual IC Time Burden (Hours)	71,303	59,601	11,702
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.