US FDA Works To Finalize 3D Printing Guidance; Industry Asks For More
A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.
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A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.
Industry, health-care providers and FDA discussed major issues in using additive manufacturing for making anatomical models at the agency's headquarters last month. The findings will be presented in a white paper from the Radiological Society of North America to help FDA figure out how to regulate the technology.
Industry stakeholders are still confused about the scope of the recently formed Combination Products Policy Council. In the meantime, the council says it doesn't have a specific timeframe by which it will address the issues industry has identified as priority topics.