Next Upcoming Seminar: Developing and Implementing SQF Systems – a Training Partnership with HACCP Consulting Group – February 6-7, 2018

Specializing in FDA Regulatory Matters

Premarket Approvals (PMA)

PMAs are essentially private licenses granted for marketing a specific device. It is illegal to market Class III devices which do not meet PMA requirements under Section 501(f). Therefore the device must undergo PMA, or the FDA may be petitioned to reclassify the device as a Class I or Class II. Petitions must include clinical studies which support the PMA or reclassification.