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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation). Imaging Compatibility and Radiotherapy Compatibility Demonstration of whether the presence of the device impacts the image quality (e.g.,

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Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Journal of Food Engineering. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109. Cardoso FS, Araujo-Lima CF, Aiub CA, Felzenszwalb I.

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