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What Are the Application Requirements for FDA Registration and Certification in the U.S.?
Category：行業(yè)資訊 Date：2024-08-29 17:13:12 Author: Source:
Ensuring compliance with these conditions is crucial for successful FDA registration and certification.

To apply for FDA registration and certification in the U.S., you typically need to meet the following requirements:7(5).jpg

  1. Device Classification: Determine the device classification (Class I, II, or III) to understand the regulatory requirements.
  2. Registration: Register your establishment with the FDA and list the device, if required.
  3. Pre-market Notification or Approval: Depending on the device class, submit a 510(k) pre-market notification or a PMA (Premarket Approval) application.
  4. Quality System Regulations (QSR): Implement and document a quality management system that complies with FDA QSR (21 CFR Part 820).
  5. Labeling: Ensure that the device labeling complies with FDA requirements, including instructions for use and warnings.
  6. Clinical Data: Provide clinical trial data if required, especially for high-risk devices.
  7. Manufacturing Information: Submit details about manufacturing processes, controls, and facilities.
  8. Financial Disclosure: Include financial disclosures related to clinical study investigators, if applicable.

Ensuring compliance with these conditions is crucial for successful FDA registration and certification.

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