Understanding and complying with the FDA’s corrections and removals process is essential for maintaining the safety and quality of medical devices. Governed by 21 CFR Part 806, this regulation requires manufacturers to take corrective actions or remove devices from the market if they pose health risks.
As the FDA begins implementing phase 1 of its lab-developed test (LDT) phaseout policy, labs must familiarize themselves with this regulation to ensure compliance. This guide offers a clear, step-by-step overview of the process, empowering labs to safeguard public health while upholding operational excellence.
read this guide
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