Certificate of Compliance w/42 CFR part 11

Premarket Approval of Medical Devices

Documents and Forms

Document Name Document Type
Form FDA 3674 Certificate of Compliance w/42 CFR part 11 Form and Instruction
FDA 3674 Certificate of Compliance (42 CFR 11) Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf Form and Instruction
FDA 3674 Certificate of Compliance (42 CFR 11) Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Certificate of Compliance w/42 CFR part 11	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 42 CFR 11

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3674	Certificate of Compliance (42 CFR 11)	Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 40	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	40	40
Annual IC Time Burden (Hours)	30	30
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.