Information Collection

Adverse Event Pilot Program for Medical Devices

IC 37668 under ICR 200709-0910-004 · OMB 0910-0471.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA Form 3669 Adverse Event Pilot Program for Medical Devices	Form and Instruction
FDA Form 3669 Device Safety Exchange Data Collection 0910-0471 DS-X.doc	Form and Instruction
FDA Form 3670 MedSun Report Form 0910-0471- MsdSun Report Form #2.doc	Form and Instruction
MedSun Additional Voluntary Questions Over Time.DOC MedSun Additional Voluntary Questions Over Time	IC Document

IC Title:

Adverse Event Pilot Program for Medical Devices

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA Form 3669	Device Safety Exchange Data Collection	0910-0471 DS-X.doc		Yes	Yes	Fillable Printable
Form and Instruction	FDA Form 3670	MedSun Report Form	0910-0471- MsdSun Report Form #2.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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	7,000	4,200	2,800
Annual IC Time Burden (Hours)	5,001	2,229	2,772
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
MedSun Additional Voluntary Questions Over Time	MedSun Additional Voluntary Questions Over Time.DOC	09/11/2007

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.