Information Collection

CDRH Rapid Message Testing with Consumers and Caregivers- November 2022 Pulse Oximeter Safety Communication

IC 262295 under ICR 202303-0910-022 · OMB 0910-0678.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0678 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Attachment A_Pulse Oximeter Accuracy and Limitations_ FDA Safety Communication _ FDA.pdf	Other-Attachment A - FDA Safety Comm
Attachment A1--11-01-22 Advisory Committee mtg page.pdf	Other-Attachment A1 - Advisory Commi
Attachment B_MSG6 Pulse Oximeters_Screener 9-27-23.docx	Other-Attachment B - Screener
Attachment C_Confirmation Email--CDRH 09-27-23.docx	Other-Attachment C - Confirmation Em
Attachment D_MSG6 Pulse Oximeters_Interview Guide_9-27-23.docx	Other-Attachment D - Interview Guide
0678-memo-#6 Pulse oximeters 9-27-23.docx OMB Memo	IC Document

IC Title:

CDRH Rapid Message Testing with Consumers and Caregivers- November 2022 Pulse Oximeter Safety Communication

Agency IC Tracking Number:

CDRH

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Attachment A - FDA Safety Communication	Yes	No	Printable Only
Other-Attachment A1 - Advisory Committee meeting web page	Yes	No	Printable Only
Other-Attachment B - Screener	Yes	Yes	Fillable Fileable
Other-Attachment C - Confirmation Email	Yes	Yes	Fillable Fileable
Other-Attachment D - Interview Guide	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 525

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	588	588
Annual IC Time Burden (Hours)	48	48
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Memo		09/27/2023

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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