Saline Breast Implant Makers Must Submit PMAs By Nov. 17, FDA Says
Manufacturers of saline breast implants have until Nov. 17 to file either a premarket approval application, product development protocol or an investigational device exemption for their products or remove them from commercial distribution, FDA says in an Aug. 19 final rule.
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At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.