510(k) Guidance

Medical device firms seeking premarket notification clearance or premarket approval in the United States are required to adhere to regulations enforced by the Food and Drug Administration (FDA).

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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