Information Collection

Medical Device Labeling; Submission of IVD Symbols Glossary

IC 247934 under ICR 202106-0910-007 · OMB 0910-0485.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0485 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0740 IVD Symbols Glossary GFI 2004.pdf file:///C:/Users/DHC/AppData/Local/Temp/2/MicrosoftEdgeDownloads/0f7bfa47-5860-46ac-9f68-48578a9688b6/FDA-2013-N-0125-0021_conte	Other-Agency Guidance
0740 IVD Symbols Glossary GFI 2004.pdf file:///C:/Users/DHC/AppData/Local/Temp/2/MicrosoftEdgeDownloads/0f7bfa47-5860-46ac-9f68-48578a9688b6/FDA-2013-N-0125-0021_conte	Other-Agency Guidance

IC Title:

Medical Device Labeling; Submission of IVD Symbols Glossary

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 801

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 3,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	3,000	3,000
Annual IC Time Burden (Hours)	15,000	15,000
Annual IC Cost Burden (Dollars)	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.