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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What You Need to Know about 510(k) Approval

The U.S. Food and Drug Administration (FDA) requires a 510(k) approval or clearance for any Class I, II or III medical device that doesn’t require a PMA. The requirement is applicable to new medical devices and iterations of existing devices.

A 510(k) submission should demonstrate the safety and efficacy of the medical device. To obtain an FDA 510(k) approval, you must be able to compare your product to similar medical devices in the market and provide substantial evidence to support its equivalency claims.

How MasterControl Can Help You

Over a dozen 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) approval, here are some of the benefits of using MasterControl Registrations:

Effective Dossier Management: MasterControl provides a single, centralized repository for all artifacts. It automates document distribution, escalation, review, and approval for a more effective dossier management. Automatic task notifications and timeline alerts will help ensure no task will slip through the cracks.

Visibility of Product Registration Projects: At a glance, you will be able to identify the countries and regions where each of your product is being registered or up for registration. Similarly, you will be able to see all your medical devices and products up for registration or re-registration in every geographic location.

Standardized Processes: MasterControl’s best-practice templates will help you avoid inconsistent filings regardless of the country or region where you are submitting regulatory filings. The system will help ensure all stakeholders are unified in their compliance and submission efforts.

Effective Milestone Management: Checklists will help ensure that stakeholders will meet their requirements within schedule. Consider them as a basic safety net. Approaching deadlines will be hard to miss.

Connectivity: Submissions for the purpose of an FDA 510(k) approval or clearance require close collaboration among multiple teams. MasterControl provides the connectivity to facilitate collaboration among your stakeholders, including consultants and vendors.

Improved Collaboration: Ineffective collaboration can jeopardize your submissions for an FDA 510(k) approval. This is especially true for organizations with teams scattered in different cities and countries. You need a virtual collaboration space that will be accessible to your stakeholders 24/7. In addition, MasterControl Registrations can be integrated with other systems (PLM, ERP, QMS, etc.) to facilitate collaboration.

Learn More About MasterControl Registrations

For more information about MasterControl Registrations, contact one of our representatives.