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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3429 Reclassification Petitions for Medical Devices Form and Instruction
FDA 3429 General Device Classification Questionnaire Form FDA 3429.pdf Form and Instruction
3427 Supplemental Data Sheet Form FDA 3427.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	FDA 3429	General Device Classification Questionnaire	Form FDA 3429.pdf		Yes	Yes	Fillable Printable
Form and Instruction	3427	Supplemental Data Sheet	Form FDA 3427.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.