MedSun

Adverse Event Pilot Program for Medical Devices

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0471 can be found here:

Documents and Forms

Document Name Document Type
Form FDA Form 3670 MedSun Form
FDA Form 3670 Medsun Submission Form 3670.doc Form

Information Collection (IC) Details

IC Title:	MedSun	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA Form 3670	Medsun Submission	Form 3670.doc		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 400	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	6,000	6,000
Annual IC Time Burden (Hours)	4,500	4,500
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.