Transfer of 510(k) Notification: Agency GFI Recommendations

Electronic Submission of Medical Device Registration and Listing

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0625 can be found here:

Documents and Forms

Document Name Document Type
Draft GFI Transfer 510(k) Clearance Q&A DEC 2014.pdf www.fdanews.com/ext/resources/files/01-15/01-05-15-transfer.pdf?1520701317 Other-Agency Guidance
Draft GFI Transfer 510(k) Clearance Q&A DEC 2014.pdf www.fdanews.com/ext/resources/files/01-15/01-05-15-transfer.pdf?1520701317 Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Transfer of 510(k) Notification: Agency GFI Recommendations	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			Draft GFI Transfer 510(k) Clearance Q&A DEC 2014.pdf	https://www.fdanews.com/ext/resources/files/01-15/01-05-15-transfer.pdf?1520701317	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 6,113	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	6,113	6,113
Annual IC Time Burden (Hours)	9,152	9,152
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.