Premarket Approval of Medical Devices: Reporting

Premarket Approval of Medical Devices

Documents and Forms

Document Name Document Type
Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff (1).pdf Other-Agency Guidance
Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff (1).pdf Other-Agency Guidance
COVID-Devices Transition-Enforcement-Guidance.pdf Other-Agency Guidance
COVID-Devices Transition-Enforcement-Guidance.pdf Other-Agency Guidance
FDA 3674 Certificate of Compliance Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf Form and Instruction
FDA 3674 Certificate of Compliance Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Premarket Approval of Medical Devices: Reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff (1).pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3674	Certificate of Compliance	Form FDA 3674 Cert of Compliance 42 CFR part 11.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance			COVID-Devices Transition-Enforcement-Guidance.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: 3,444	Number of Respondents for Small Entity: 500

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,444	-1,652	5,096
Annual IC Time Burden (Hours)	343,466	-41,470	384,936
Annual IC Cost Burden (Dollars)	0	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.