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One of the ways that the FDA ensures the safety and effectiveness of medical devices is by establishing performance standards, which are rules that specify the minimum requirements for certain aspects of device design,…
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Three Classes of Regulatory Control The FDA classifies devices into one of three classes based on their risk and regulatory oversight. Class Risk Level Controls Examples I Low General Bandages, tongue depressors, dental floss…
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The FDA requires certain medical devices to have a unique device identifier (UDI) that can be used to identify and track them throughout their distribution and use. A UDI is a code that consists…
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Postmarket surveillance (PMS) is the process of monitoring the safety and effectiveness of medical devices after they have been approved or cleared for marketing by the FDA. PMS can help identify unforeseen adverse events,…
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The point medical device tracking regulation is make sure the FDA, manufacturers, distributors, and patients can track certain devices from the manufacturing to the patient. The main reasons to do this are: to ensure…
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This article provides an overview of the key parts of 21 CFR Part 820, also called the Quality System Regulation, or just QSR, so called because it tells medical device manufacturers, importers, and distributors…
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The FDA needs to agree a medical device is reasonably safe and effective before you can sell it in the US. For Class III (high risk devices), this agreement is called ‘approval’. To get…
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The FDA needs to agree a medical device is reasonably safe and effective before you can sell it in the US. For Class II (moderate risk devices), this agreement is called ‘clearance’. To get…
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Investigating A Medical Device Consider this Catch-22: You can’t distribute a medical device before getting FDA approval. You can’t get FDA approval without evidence the medical device works. You can’t get evidence a device…
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Recalls are ‘Voluntary’… …Until They Are Not 21 CFR Part 810 is one of the more serious and impactful regulations for most medical device manufacturers to understand, as it can impact a company’s reputation…
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This regulation contains the labeling requirements for in vitro diagnostic products, which are devices or biological products used for testing specimens from the human body. Due to their special nature, the labeling requirements are…
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Federal Preemption Have you ever wondered why each State doesn’t have their own laws about medical devices? 21 CFR Part 808, for the most part, preempts (i.e. prevents) states and localities from making their…
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In my opinion, registration and listing is the simplest and most intuitive regulation for medical devices. It’s a quick and fairly painless online process if you read and follow FDAs detailed instructions. Device Registration…
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What is a Recall? ‘Recall’ of a medical device is when a manufacture takes action to address a problem with a device that violates FDA law OR has a defect that could be a…
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Overview of 21 CFR Part 803 This regulation describes rules for reporting adverse events to the FDA and states how these reports may be shared with the public. Adverse events include, but are not…
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With the latest FDA proposed rule-making for IVDs, laboratory professionals supporting Laboratory Developed Tests (LDTs) may be asking, what does this mean for my LDT test? In short—the FDA wants to regulate LDTs under…
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The FDA has published a proposed rule to amend 21 CFR Part 809 (in vitro diagnostic) regulations to state that laboratory developed tests (LDTs) are in vitro diagnostic products (IVDs) designed, manufactured and used…
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