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What documents are required for FDA registration in the United States?
Category：行業(yè)資訊 Date：2024-11-12 16:57:58 Author: Source:
To register a medical device with the FDA in the United States, you typically need the following documents:

To register a medical device with the FDA in the United States, you typically need the following documents:7.jpg

  1. Device Establishment Registration – Register the manufacturing facility with the FDA.
  2. 510(k) Pre-market Notification (if applicable) – For devices that are not exempt from pre-market approval.
  3. Device Listing – A listing of all devices manufactured or imported for distribution.
  4. Labeling Information – Labels and labeling to meet FDA requirements.
  5. FDA Form 2877 – Declaration for Imported Devices (if applicable).
  6. Quality System Documentation – Proof of compliance with FDA's Quality System Regulation (QSR).
  7. Risk Management Data – Documentation regarding risk analysis and management, as per FDA guidelines.
  8. Clinical Data – If applicable, clinical trial results to support the device's safety and efficacy.

Additional documents may be required depending on the device classification and risk level.

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