Premarket Approval of Medical Devices

ICR 202211-0910-010

OMB: 0910-0231

Federal Form Document

Forms and Documents

Document Name	Status
Form FDA 3674 Certificate of Compliance w/42 CFR part 11 Form and Instruction	New
0231 PMAs SSA REV.docx Supporting Statement A	2023-03-30

IC Document Collections

IC ID	Document Title	Status
5826	Premarket Approval of Medical Devices: Reporting Other-Agency Guidance	Modified
257032	Certificate of Compliance w/42 CFR part 11 Form and Instruction	New
209459	Premarket Approval of Medical Devices: Maintenance of Records	Modified