Information Collection Request

Investigational Device Exemptions

ICR 202210-0910-013 · OMB 0910-0078 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0078 can be found here:

Forms and Documents

Document Name	Status
0078 IDEs SSA 2022 Rev.docx Supporting Statement A	2022-11-20
0078 Change Request to include 0741 MAY 2021.docx Justification for No Material/Nonsubstantive Change	2021-05-24
0078--change request--moving OUS to 0078--05-06-21.pdf Justification for No Material/Nonsubstantive Change	2021-05-14

IC Document Collections

IC ID	Document Title	Status
5718	IDE Reporting (including reports for nonsignificant studies)	Modified
205261	Third Party Disclosures	Removed
205260	IDE Recordkeeping	Modified

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0078
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202104-0910-011
Agency Tracking No	CDRH
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31