Medical Devices; Humanitarian Use Devices

ICR 202303-0910-005

OMB: 0910-0332

Federal Form Document

Forms and Documents

Document Name	Status
Form FDA 3674 Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) Form	New
Form FDA 3674 Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) Form	New
83-C for 0332 to add certification element under 0616 MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-12
83-C for 0332 to add certification element under 0616 MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-12
0332_Supporting Statement_2022.docx Supporting Statement A	2022-09-09
0332_Supporting Statement_2022.docx Supporting Statement A	2022-09-09

IC Document Collections

IC ID	Document Title	Status
5922	Medical Devices; Humanitarian Use Devices	Unchanged
258995	Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) Form	New
258995	Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) Form	New
255790	Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements Other-Agency Guidance	Unchanged