Demand for micro-sized products is prompting micromolders to develop new processes and methods that are outside the norm of standard injection molding.
Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.
Progress in assembly and automation technologies enable manufacturers to leverage capabilities such as Industry 4.0 and IoT for medical device fabrication.
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