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Premarket Approval Process
A rigorous FDA approval process required for certain medical devices to assess their safety and effectiveness before they can be marketed.
Government Regulation
The imposition of rules and directives by government agencies designed to control and direct the behavior of individuals, businesses, and other entities in the public interest.
Design Defect
A flaw or error in the design of a product that makes it dangerous or ineffective, potentially leading to consumer harm or product failure.
Product Liability
refers to the legal obligation of manufacturers, suppliers, or sellers to compensate for injuries or damages caused by defective or unsafe products.
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