(Burden Change Due to Rulemaking) De Novo Request

Medical Device De Novo Classification Process

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0844 can be found here:

Documents and Forms

Document Name Document Type
NEW_Guidance_8-2017.docx Other-Guidance: De Novo Classificati

Information Collection (IC) Details

IC Title:	(Burden Change Due to Rulemaking) De Novo Request	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 860.201 21 CFR 860.223 21 CFR 860.234 21 CFR 860.245 21 CFR 860.256

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation)			NEW_Guidance_8-2017.docx		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 60	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	60	34	26
Annual IC Time Burden (Hours)	10,920	8,320	2,600
Annual IC Cost Burden (Dollars)	7,278	7,278	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.