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FDA PMA Process for IVD Companies



 
Our Price: $395.00

Product Code: WB-8
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About the Product
Contains video file.

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Ensuring a firm understanding of the regulatory pathways for new IVD products is critical in an atmosphere of increased market competition and need for early market release. The PMA process is costly, time-consuming, and complex and can put a strain on the resources of an IVD company. This audio conference will discuss the PMA process from an FDA perspective.
  • When is a PMA necessary?
  • Comparison of the PMA and 510(k) processes
  • How to avoid the potential pitfalls of the PMA process

Speakers
:
Sally Hojvat, PhD
Director of the Division of Microbiology Devices
FDA

Kathleen Simon, PhD
Scientific Reviewer in the Division of Microbiology Devices
FDA


Zivana Tezak, PhD
Scientific Reviewer
FDA


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