By Angela Brown
The Food and Drug Administration (FDA) recently issued reports on April 29, 2015 – 2014-2015 Strategic Priorities and 2014 – 2015 Strategic Priorities Strike the Right Balance Between Premarket and Postmarket Data Collection – to the public to report on their progress toward meeting the established 2014-2015 objectives. This year their focus is on strengthening the clinical trials enterprise; striking the right balance between premarket and postmarket data collection; and providing excellent customer service.
This guidance is released on the heels of another newly released guidance, Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions on April 13, 2015. Of particular interest with regard to FDA’s strategic priorities is their consideration for about half of the reviewed product codes to shift requirements to the postmarket environment, as well as to reduce premarket studies and even down classify codes. FDA has already implemented the reclassification of 2 product codes and shifted data collection to post market on one in 2014. The products under consideration of changes to clinical studies, either by reduction or shifting, fall mostly within the areas of Pathology, Immunology, and General & Plastic Surgery; specifically, breast implants. As for reclassification, the FDA has identified products from many areas including Radiology, Gastroenterology/Urology, and General & Plastic Surgery, including photodynamic (laser) therapy systems.
FDA’s goal was to review 50% of all Premarket Approval device types. Not only did the FDA meet their goal, they exceeded it by completing 69% of the device type reviews and they expect to reach 100% completion by the end of this year. As there have been many candidates identified in this review, these are not yet finalized and most of the product codes reviewed remain unchanged.