Month: July 2024

The FDA has declared a Final Rule to phase out the enforcement discretion for laboratory developed tests (LDTs), aligning them with the regulatory framework applied to in vitro diagnostics (IVDs). This change, to be published in the Federal Register on May 6, 2024, and available in a PDF version beforehand, signifies a significant shift for […]

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As of now, I’m unable to access the full content of the article titled “BY AMANDA CONTI” as the provided text seems to be part of a prompt or introduction inviting readers to fill out a form to access the entire piece. Based on the given excerpt, the article discusses a new question-and-answer draft guidance […]

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Failure Mode and Effects Analysis (FMEA) is a method commonly used to identify potential failures in a product or process design. However, in specialized fields like MedTech, FMEA is not the ideal risk management tool. MedTech primarily relies on ISO 14971:2019, which outlines risk management for medical devices. This article explores the differences between FMEA […]

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The FDA’s Center for Devices and Radiological Health has entered into a partnership with the Bill and Melinda Gates Foundation to enhance diagnostic development, supported by a $1.9 million grant from the Gates Foundation. This collaboration aims to devise novel analytical methods geared towards the advancement of breath-based diagnostic tools specifically designed for diseases prevalent […]

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