FDA recommends moving away from using duodenoscopes with fixed endcaps due to challenges cleaning them for reuse and persistent high contamination levels.
The agency believes that additional changes are needed to fully modernize the 510(k) program.
Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration04.30.19
FDA has determined the manufacturers, Boston Scientific and Coloplast, haven't demonstrated reasonable assurance of safety and effectiveness for these devices.
t:Slim X2 is the first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices.
The 510(k) program must keep pace with the important innovations FDA is seeing in device development.
Scott Gottlieb, M.D., Commissioner; Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health;, U.S. Food and Drug Administration01.23.19