FDA 510(k) Approval

If your company plans to sell a medical device in the United States, you’re going to need a premarket notification, also known as FDA 510(k) approval or clearance for any device not subject to a premarket approval (PMA) or exempted under the Federal Food, Drug and Cosmetic Act.

MasterControl Registrations is a dossier management and product registration solution designed to facilitate your submission for an FDA 510(k) approval. The solution will automate your manual or hybrid processes, track various requirements for every market where you are registering your device, and create transparency for effective monitoring of requirements.

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