OMB control number
Premarket Approval of Medical Devices
OMB 0910-0231 · HHS/FDA.
This information collection supports implementation of statutory requirements that govern premarket approval of medical devices. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Respondents to the information collection are PMA applicants, or persons who own the rights, or otherwise have authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity.
The latest form for Premarket Approval of Medical Devices expires 2026-05-31 and can be found here.
Document Name |
|---|
Form and Instruction |
Supporting Statement A |
Form FDA 3674 Certificate of Compliance w/42 CFR part 11
0231 PMAs SSA REV.docx
Premarket Approval of Medical Devices: Reporting Premarket Approval of Medical Devices: Reporting
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form FDA 3674 | Certificate of Compliance | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.