In the United States, most new medical devices are launched through the FDA’s 510(k) clearance process. Device manufacturers must take advantage of the FDA database for 510(k) clearances if they are planning to make any equivalence claims.
If your company is developing a product similar to a medical device that already exists, you must search in the FDA 510(k) database for the predicate device most similar in characteristics and indications to your product.
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If your firm is pursuing a device clearance, MasterControl Registrations can help you manage your product dossier and registrations submission regardless of the phase you are in. The cloud-based solution will automate your manual or hybrid processes, track various requirements for every market where you plan to register your device, and create transparency for effective monitoring of requirements.
The U.S. Food and Drug Administration established the FDA database for 510(k) clearances to serve as a repository for classification information about medical devices that have been cleared by the agency under the premarket notification process or what’s known as 510(k) process.
To apply for a 510(k) clearance, a device manufacturer must prove substantial equivalence to a device already in the market, also called a predicate device. When searching the FDA 510(k) database for predicate devices, take note of the marketed names of the devices, their manufacturers, marketing status of the device, and classification information, which includes product codes and classifying regulations.
Major U.S. federal and state agencies, including divisions of the world’s largest and most recognized regulatory agency, have chosen MasterControl solutions. If your company is seeking a 510(k) clearance for a device, MasterControl Registrations can help you ensure a faster time to market. Here are some of the benefits of using MasterControl:
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