FDA Approval

Products to be developed from BREONICS' technologies must meet the requirements for medical devices and/or pharmaceuticals in order to gain governmental approval before production and marketing can commence.

In the United States the Federal Food and Drug Authority (FDA) oversees and administers the regulatory approval process. These duties are performed by similar agencies in Europe and other foreign countries. The process for acquiring regulatory approval is costly and time consuming. Generally both pharmaceuticals and class III medical devices must undergo pre-clinical and clinical trials prior to the filing of a NDA (New Drug Application), in the case of pharmaceuticals or a PMA (Pre Market Approval), in the case of medical devices. These filings must be made and supported before FDA approval can be attained.

At a preliminary panel meeting between BREONICS and the FDA it was agreed that EMS products for clinical transplantation would be considered in the category of Medical Devices and would require a PMA. However, the FDA panel also suggested that because of the critical need to provide more organs for transplantation that EMS may qualify for an expedited clinical trial and review.