Investigational Device Exemptions

ICR 202210-0910-013

OMB: 0910-0078

Federal Form Document

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