All medical devices are not made equal. They are not regulated the same way, either. Most medical devices enter the U.S. market through a 510(k) clearance process, also called the premarket notification process. If your device falls under this category, you are going to need a 510(k) application.
MasterControl Registrations, a cloud-based solution, can help you automate your manual system and manage your product dossier for an effective 510(k) application in the United States and similar regulatory submissions in other countries.
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Medical device manufacturers preparing a 510(k) application may wonder what 510(k) means. It’s not a form, but a section of the Federal Food, Drug, and Cosmetic Act. A 510(k) clearance is required for any device considered an equivalent in function or purpose and effectiveness to an existing device (called predicate device) in the market.
To submit a 510(k) application for your new device, it doesn’t have to use exactly the same technology or material as the predicate device. Companies that plan to manufacture a device with additional indications may submit a 510(k) application, citing a predicate device. Later on, they may submit a second 510(k) application for other indications.
MasterControl is the provider for a number of U.S. federal and state agencies, including divisions of the world’s largest and most recognized regulatory agency. If your company is pursuing a 510(k) application for a device, you can rely on MasterControl Registrations to facilitate your submission for a faster time to market.
MasterControl can help you in these areas:
For more information about MasterControl Registrations, please feel free to contact a MasterControl representative.