Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation

Implementation of Sections 222, 223 and 224 of the Food and Drug Administration Act of 2007

⚠️ Notice: This information collection may be referencing outdated material.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 3673 Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation Form and Instruction
3673 Device registration & Listing Module Form FDA 3673 Device Regs & Liasting Module.doc Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting- Initial Registration & Listing Requirements for Medical Device Establishments Not Previously Entered Into An Operation	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 807.22 ( a )

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3673	Device registration & Listing Module	Form FDA 3673 Device Regs & Liasting Module.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,566	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	Program Change Due to New Statute
Annual Number of Responses for this IC	2,566	2,566
Annual IC Time Burden (Hours)	1,283	1,283
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.