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What Are the Specific Technical Standards for FDA Certification of Medical Devices?
Category：行業(yè)資訊 Date：2024-09-14 16:32:40 Author: Source:
Devices must comply with these standards to demonstrate safety, effectiveness, and quality before FDA approval.

The specific technical standards for FDA certification of medical devices depend on the type of device and its intended use. Generally, they include:7(1).jpg

  1. ISO Standards: Various International Organization for Standardization (ISO) standards, such as ISO 13485 for quality management systems and ISO 14971 for risk management.
  2. ANSI Standards: American National Standards Institute (ANSI) standards relevant to specific device types.
  3. IEC Standards: International Electrotechnical Commission (IEC) standards, such as IEC 60601 for medical electrical equipment.
  4. FDA-Specific Guidelines: FDA’s own guidelines and requirements for device safety and efficacy, such as those outlined in the Code of Federal Regulations (CFR), including Title 21.

Devices must comply with these standards to demonstrate safety, effectiveness, and quality before FDA approval.

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