I3CGLOBAL FDA 510k January 20, 2023 Performance Tests – Bench, Animal, Clinical Most 510(k) submissions will include some type of performance data. The extent of performance data w... Read More
I3CGLOBAL Biocompatibility Testing, FDA 510k, Resources June 30, 2022 FDA 510k Biocompatibility Assessment * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
I3CGLOBAL FDA 510k January 22, 2022 Surgical Sutures FDA 510k * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
ShareThoughts FDA 510k, Resources February 11, 2021 Sampling Size for Performance Testing ... Read More
ShareThoughts FDA 510k February 11, 2021 Barrier Performance Classification of Face Masks ... Read More