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.
What You Need to Know about FDA 510(k) Database
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.
How MasterControl Can Help You
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:
- Manage Product Dossier Effectively: If you use a paper-based or partially
electronic dossier management system, MasterControl will automate your process and provide a centralized
repository for all regulatory artifacts. Document distribution, escalation, review, and approval will be
automated for a more effective dossier management. With an automatic task notification, no tasks will fall
through the cracks.
- Keep Product Registration Projects Visible to All Stakeholders: With MasterControl
Registrations, you will be able to identify the countries where each of your device is either up for
registration/re-registration or in the process of being registered. In the same vein, you will be able to
see all your products in every geographic location.
- Manage Project Milestones Effectively: Project transparency is key to managing milestones
effectively. Timeline notifications will make sure all team members are aware of approaching deadlines for
individual tasks and overall submissions.
- Standardize Processes for Consistency: The phase of searching the FDA 510(k) database will
be followed by the nuts and bolts of content generation and compilation for your dossier. MasterControl will
provide you with best-practice templates for consistent filings regardless of the country or region where
you are submitting. The solution also comes with checklists so no regulatory requirements are overlooked.
Even if your stakeholders are scattered throughout the world, the system will help ensure your compliance
and submission efforts are consistently compliant.
- Connect All Stakeholders under a Single Platform: An application for premarket notification
clearance entails close collaboration among different teams. One of the key advantages of MasterControl is
the capability to provide a single platform that will connect all stakeholders, including outside
consultants and vendors.
- Improve Collaboration in Real Time: To stay competitive, your organization must be agile
enough for rapid changes in the regulatory landscape. Contributors to the content of your product dossier
need the capability for simultaneous editing, preferably in real time. MasterControl Registrations will
provide you access to a virtual collaboration space 24/7.
Learn More About MasterControl Registrations
For more information about MasterControl Registrations, contact one of our representatives. To learn more about FDA database for 510(k)
clearances, visit the FDA website.