510(k) Application

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.

Free Resources

Select all the resources you’re interested in downloading

What You Need to Know about FDA 510(k) Application

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.

How MasterControl Can Help You

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:

  • Product Dossier Management: Automating your paper-based or hybrid processes is the first step to improving your dossier management. With MasterControl Registrations, you will streamline the distribution of tasks and documents, escalation, review, and approval through automation. You will be able to address any changes to the contents of your product dossier in real time.
  • Management and Control of Granularity: The more devices you have and the more countries you plan to introduce them, the more variables in your requirements. MasterControl will provide robust tools to help you keep up with the granularity of every registration and re-registration project.
  • Visibility of Registration Projects: One of the worst aspects of a manual system is its lack of visibility, which could lead to submission delays. Project visibility is crucial if you want your stakeholders to be proactive in performing their tasks. With MasterControl Registrations, you will easily see the countries and regions where your device is being registered. In a similar fashion, you will readily see the products registered in every location.
  • Management of Product Registration Milestones: Product expirations, registration deadlines, and compliance requirements in different markets all represent moving targets. MasterControl will equip your team with the right tools for tracking down changes in your projects, flagging down any delays, alerting you about approaching deadlines, and managing your milestones.
  • Standardized Processes: Repurposing product information and data is a big part of preparing regulatory submissions. MasterControl’s templates will help standardize your filings regardless of the region where you are submitting. The system allows you to customize a checklist based on a template for a country.
  • Team Collaboration: If your organization uses different systems for different teams or business units, such disparity could weaken collaboration. MasterControl Registrations will provide you with a virtual collaboration space to help bridge the physical distance.
  • Integrated Platform: For a successful 510(k) application, you are going to need a single “source of truth” for all your stakeholders. If you have facilities and team members in different cities and countries, it’s hard to ensure that the entire organization is using current, approved documentation. MasterControl will give you the capability to connect your teams, including outside consultants and vendors, through integration. It will provide a single, centralized repository for all submission artifacts.

Learn More About MasterControl Registrations

For more information about MasterControl Registrations, please feel free to contact a MasterControl representative.