Medical device manufacturers have a new tool available to demonstrate substantial equivalence through FDA’s 510(k) Safety and Performance measures. In a recently released Final Guidance, the Agency, as part of their effort towards stimulating innovation and reducing administrative burdens, all while keeping a keen eye on safety, is adding to their arsenal of abbreviated device submissions available for products based on previously approved predicates. Read more about FDA’s latest initiative in an EAS authored blog published by ISPE and contact Bryan Coleman, Senior Director for Pharmaceuticals and Medical Devices, to learn more about EAS services to support Medical Device manufacturers and their development of innovative new products.
Posted in EAS in Action, EASeNews, Medical Devices and tagged Amy Scanlin, Bryan Coleman.