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

Testing Communications On Medical Devices and Radiation-Emitting Products

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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

Information Collection (IC) Details

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:

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 %

	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

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.