Oct 12, 2023
CDRH
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...
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Oct 6, 2023
CDRH
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...
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Apr 15, 2022
FDA
The new article highlights certain specific aspects to be considered, including design controls and following steps in clinical evaluation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Apr 11, 2022
FDA
The new article is dedicated to iterations during early feasibility studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Mar 30, 2022
FDA
The new article provides additional details regarding specific aspects related to the report of prior investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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