Manufacturers that launch their devices under the premarket notification process should follow all 510(k) guidance documents. The FDA’s “How to Prepare a Traditional 510(k)” guidance provides a detailed instruction.
If your company is like most device manufacturers, you probably want to register your products in more than one country. MasterControl Registrations, a cloud-based solution, can help you manage your product dossier for submissions worldwide. If you still use a manual or hybrid system, MasterControl can automate your processes to help you improve efficiency and ensure compliance with FDA 510(k) guidance documents and other regulations.
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