Premarket approval is the FDA process to evaluate a Class III device. This classification has the most stringent review and is reserved for those devices, blood devices or biologics that support or sustain human life, or may have substantial impact on human health, or present a potential for risk or illness. Class III devices are reviewed with exacting scrutiny by the FDA. Smith Associates has the experience to guide your company through this process. As consultant for MedMira of Canada, MedMira has received their PMA for a Rapid HIV Test Kit. Smith Associates can assist you in determining what PMA approach best suits your product: Traditional PMA Modular PMA Streamlined PMA Product Development Process Humanitarian Device Exemption ABOUT US Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English