Quality

FDA 510(k) Database for Medical Devices

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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Free Resources for Medical Devices Compliance

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Industry Brief: Reducing the Documentation Burden in FDA Design Control
White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along? White Paper: 10 Common Pains in Dossier Management & Product Registration
Data Sheet: Manufacturing Quality: Frictionless Quality and Compliance With eDHR
Solution Overview: MasterControl Regulatory Excellence

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.