Frequently Asked Questions

What is a Pre-Market Approval (PMA)?

No items found.
FDA Clearance
Compliance & Regulatory: MedTech
Guidelines & Standards

A Premarket Approval (PMA) application is a scientific, regulatory documentation to the FDA. The purpose is to demonstrate the safety and effectiveness of the Class III device. There are administrative elements of a PMA application, but good science and scientific writing is key to the approval of PMA application.

If a PMA application lacks elements listed in the administrative checklist, FDA will refuse to file it, and if a PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could impact FDA's review and approval.