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What are the core review standards for FDA registration of medical devices?
Category：行業(yè)資訊 Date：2024-07-22 16:48:28 Author: Source:
Adherence to these core review standards is essential for manufacturers seeking FDA registration of their medical devices, ensuring that devices meet rigorous regulatory requirements and contribute to patient safety and public health.

The core review standards for FDA registration of medical devices focus on ensuring the safety, effectiveness, and quality of devices intended for market entry in the United States. These standards include:7(1).jpg

  1. Safety: Devices must demonstrate that their design, materials, and manufacturing processes pose minimal risk of harm to patients, users, and others involved in their use.

  2. Effectiveness: Manufacturers must provide evidence, typically through clinical data or performance testing, that the device performs as intended and achieves the claimed therapeutic benefits under specified conditions of use.

  3. Quality: Devices must comply with FDA's Quality System Regulation (QSR) requirements (21 CFR Part 820), ensuring that they are consistently manufactured, packaged, and labeled according to established quality standards.

  4. Compliance: Manufacturers must adhere to all applicable FDA regulations and guidelines regarding device classification, labeling, and any special controls or requirements specific to the device type or intended use.

  5. Documentation: Complete and accurate documentation must be provided to support the device's safety, effectiveness, and compliance throughout its lifecycle, from premarket submission through post-market surveillance.

  6. Labeling: Device labeling must be clear, accurate, and informative, providing essential information for safe and effective use, including indications for use, contraindications, warnings, precautions, and instructions for use.

  7. Post-Market Responsibilities: Manufacturers must commit to ongoing monitoring of device performance through post-market surveillance, adverse event reporting, and compliance with FDA requirements for corrections and removals.

Adherence to these core review standards is essential for manufacturers seeking FDA registration of their medical devices, ensuring that devices meet rigorous regulatory requirements and contribute to patient safety and public health.

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