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FDA 510(k) Submission Requirements
FDA 510(k) Submission Requirements

Learn the FDA 510(k) Submission Requirements with this Action List

In general, manufacturers of Class II medical devices are required to submit a 510(k) to the FDA. Medical devices that contain software components or are composed solely of software have particular steps to go through to achieve FDA 510(k) clearance. With this easy-to-follow high-level check list, you’ll learn the key elements of FDA 510(k) Submission Requirements, including:

  • Summaries & statements
  • Performance & safety testing
  • Specific inclusions for software

Still feeling overwhelmed? Give us a call, and we’ll connect you with one of our regulatory affairs experts.

Please note: This Action List is not intended as regulatory advice for any particular medical device. You should consult with your regulatory affairs consultant to determine the appropriate regulatory roadmap for your particular medical device.

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510(k) Action List