Reclassification Petitions for Medical Devices

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0138 can be found here:

Documents and Forms

Document Name Document Type
Form 3429 Reclassification Petitions for Medical Devices Form and Instruction
3429 FDA Form 3429 Form FDA 3429 7-24-12.doc Form and Instruction
3427 FDA Form 3427 Form FDA 3427 Final.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reclassification Petitions for Medical Devices	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 860.123

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3429	FDA Form 3429	Form FDA 3429 7-24-12.doc		Yes	Yes	Fillable Printable
Form and Instruction	3427	FDA Form 3427	Form FDA 3427 Final.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 6	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	6	6
Annual IC Time Burden (Hours)	3,000	3,000
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.