When these regulations and practices are followed, they provide reasonable assurance that the device is safe and effective.įDA has also issued device-specific guidance for some products so that manufacturers understand the Agency’s expectations. For PPE, these standards may include for fluid resistance, leak protection, filtering capacity, or resistance to tears and snags. Manufacturers are expected to use these regulations and practices to maintain consistent product quality and to guide performance testing to make sure that their products conform to recognized consensus standards. To help ensure medical devices, including PPE are safe and effective, the FDA has established Quality Systems Regulations and Good Manufacturing Practices. How do manufacturers ensure personal protective equipment (PPE) is safe and effective?Ī1.
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