Master the 510(k) Pathway and Enter the US Market
The 510(k) premarket notification remains one of the most widely used routes to the United States market for medical devices. In fact, approximately half of the medical devices used in the US each day have been cleared for commercialization by the Food and Drug Administration (FDA) through the 510(k) pathway. While the 510(k) process is often used, it is also often misunderstood. This leads to delays in commercialization and access to innovative products by the patients and providers who need them.
OnemataDC can help you move through the 510(k) submission process efficiently and successfully. Our Regulatory Affairs team designs custom 510(k) strategies and deploys best practices at each step of the process developed from our collective decades of experience. Whether you’re at the beginning and don’t know where to start, getting ready to start the process, or have submitted a 510(k) and are encountering issues during the review, we can help you at any stage and guide you to success.
510(k) Submission Services
The FDA 510(k) submission process is complex and can be challenging for companies, especially those unfamiliar with the regulatory requirements. An experienced regulatory professional is instrumental in guiding you through the process of obtaining clearance for medical devices that require a 510(k). Our skilled regulatory consulting team ensures what's often a convoluted and fraught process is navigated smoothly by thoroughly understanding the device and anticipating any potential obstacles. With the help of highly qualified and experienced experts, the clearance process can be completed with a high likelihood of success.
Each 510(k) submission project is tailored precisely to your needs. Examples of how we can support you include, but are not limited to:
510(k) Strategy
Develop creative, well-researched strategies, including testing recommendations, predicate identification and device class, regulation number and product code determination.
Submission Authoring
Write each applicable 510(k) and submit to FDA via eSTAR.
Documentation Development & Review
Develop and/or review 510(k) supporting documentation, such as software documentation, device and package labels, and instructions for use.
FDA Liaison Services
Advise on how and when to interact with FDA, and interact with FDA on your behalf, both prior to (part of a Q-Sub) and/or during the 510(k) submission review.
Review Process Support
Monitor the review process and provide strategy and support for Additional Information requests.
Post-Clearance Assistance
Provide guidance and support on regulatory and quality requirements prior to commercialization, such as full 21 CFR 820 compliance, advertising material review and establishment registration and device listing.
Establish and maintain a US market presence.
Contact us today to take the first step toward bringing your device to market efficiently and successfully. A flawed submission will delay your product launch for several months—perhaps longer.
Our well-rounded, experienced team has successfully worked with nearly every Office, Division and Branch within the Center for Devices and Radiological Health (CDRH) at FDA, and no one is better suited to help you reach your goals.