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An Ingredient List for Your Medical Device?

Published In: MDDI Online

On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for a broader range of medical devices to both healthcare providers and patients. This idea began from safety concerns with various long-term devices that have received public scrutiny (such as breast implants and metal-on-metal hip implants). With these realized patient risks, it is understandable why FDA is asking for feedback regarding how to best communicate any possible safety hazards to clinicians and patients so that they can make an informed decision understanding the acceptable risks.


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