Information Collection

CDRH Rapid Message Testing with Consumers and Caregivers-Web Content About Recently-Approved Medical Devices

IC 258459 under ICR 202206-0910-013 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Web Content Attachment A Landing Page.pdf	Other-Web content of recently approv
Web Content Attachment B Eversense 2-10-2023.pdf	Other-Web content Eversense E3
Web Content Attachment C RHA Redensity 2-10-2023.pdf	Other-Web content RHA Redensity
Web Content Attachment D MiSight Contact Lenses 2-10-2023.pdf	Other-Web content contact lenses
Web Content Attachment E Screener 2-10-2023.docx	Other-Screener
Web Content Attachment F Interview Guide 2-10-2023.docx	Other-Interview guide
0678 OMB Memo - Web Content Recently Approved Devices 2-10-2023.docx OMB Memo / Abbreviated Supporting Statement	IC Document

IC Title:

CDRH Rapid Message Testing with Consumers and Caregivers-Web Content About Recently-Approved Medical Devices

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	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Web content of recently approved devices	Web Content Attachment A Landing Page.pdf	Yes	No	Printable Only
Other-Web content Eversense E3	Web Content Attachment B Eversense 2-10-2023.pdf	Yes	No	Printable Only
Other-Web content RHA Redensity	Web Content Attachment C RHA Redensity 2-10-2023.pdf	Yes	No	Printable Only
Other-Web content contact lenses	Web Content Attachment D MiSight Contact Lenses 2-10-2023.pdf	Yes	No	Printable Only
Other-Screener	Web Content Attachment E Screener 2-10-2023.docx	Yes	No	Fillable Fileable
Other-Interview guide	Web Content Attachment F Interview Guide 2-10-2023.docx	Yes	No	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 450

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	450	450
Annual IC Time Burden (Hours)	36	36
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Memo / Abbreviated Supporting Statement	0678 OMB Memo - Web Content Recently Approved Devices 2-10-2023.docx	02/10/2023

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