The International Standards Organisation (ISO) recently published a new technical standard, ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents.
On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its "intended use" rule due to concerns raised by the industry.
There's frequently a flurry of FDA announcement near the end of the year, and this year was no exception. We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers. The summaries below link to some of the more interesting guidance documents recently released.
On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices. The document "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff" is meant to outline the agency's current thinking about devices made via these processes and will be supplemented by a webinar in January. More information on the webinar is available here.