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How many steps are there in applying for FDA certification in the United States?
Category：行業(yè)資訊 Date：2024-08-05 16:03:34 Author: Source:
These steps may vary depending on the specific type and classification of the medical device. It's essential to follow FDA guidance and requirements closely throughout the application process.

Applying for FDA certification in the United States generally involves several key steps:7(1).jpg

  1. Device Classification: Determine the appropriate classification of the medical device based on FDA regulations.

  2. Premarket Notification (510(k)) or Premarket Approval (PMA): Prepare and submit either a 510(k) notification for low to moderate-risk devices or a PMA application for high-risk devices.

  3. Quality System Regulation (QSR) Compliance: Ensure compliance with FDA's Quality System Regulation, including establishment registration and device listing.

  4. Submission Review: FDA reviews the submitted application or notification for completeness and compliance with regulatory requirements.

  5. Additional Information Requests: Respond to any requests for additional information or clarification from the FDA.

  6. Review and Decision: FDA evaluates the submitted data and makes a decision on the approval or clearance of the device.

  7. Post-market Surveillance: Once approved, comply with FDA regulations for post-market surveillance and reporting requirements.

These steps may vary depending on the specific type and classification of the medical device. It's essential to follow FDA guidance and requirements closely throughout the application process.

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