About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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.

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