Information Collection

Premarket Approval of Medical Devices: Reporting

IC 5826 under ICR 202211-0910-010 · OMB 0910-0231.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0231 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.