The US Food and Drug Administration (FDA) is planning to update its almost 40-year-old regulatory processes for approval of medical devices by adding a voluntary alternative alongside the existing 510(K) pathway, according to commissioner Scott Gottlieb. He said identifying "sufficient, appropriate predicate devices" for testing sometimes stood in the way of innovation, and the new FDA framework would be open to pre-specified mature device categories that met or exceeded the criteria applying to products already on the market. Gottlieb also announced he was launching an online tool called FDAFacts.org, which will provide consumers with information about how their personal health data are being used against them when they use consumer products.
The US Food and Drug Administration (FDA) is planning to update its almost 40-year-old regulatory processes for approval of medical devices by adding a voluntary alternative alongside the existing 510(K) pathway, according to commissioner Scott Gottlieb. He said identifying "sufficient, appropriate predicate devices" for testing sometimes stood in the way of innovation, and the new FDA framework would be open to pre-specified mature device categories that met or exceeded the criteria applying to products already on the market. Draft guidance on the voluntary pathway is set to be released early next year.