US FDA 510(k) Submission Services for Medical Devices & IVDs

Get expert support for US FDA 510(k) approval. Our team guides you through Traditional, Special, and Abbreviated 510(k) submissions, ensuring smooth medical device clearance. With timely solutions to critical project aspects, in-depth knowledge of FDA requirements, and close collaboration with accredited testing facilities, we streamline the submission process. This makes MAVEN your one-stop solution for US FDA submissions, registrations, and listings.

1. US FDA 510(k) Submission Services for Medical Devices & IVD www.mavenprofserv.com

2. What is FDA 510(k)? Premarket Submission Required before selling medical devices in the US Substantial Equivalence Demonstrates similarity to legally marketed predicate device Moderate Risk For devices with established benchmarks, less complex than PMA

3. FDA 510(k) Consultant Responsibilities Strategy & Planning Identify suitable pathway based on device type Documentation Compile technical files and ensure compliance FDA Communication Respond to queries and information requests

4. Types of 510(k) Submissions Traditional Most common type. Full submission for new devices. Special For modifications to your own cleared device. Faster review. Abbreviated Uses FDA guidance documents and standards. Reduced data needed.

5. Predicate Device Requirements Substantial Equivalence Same Intended Use Must serve the same medical purpose Similar Technology Comparable design, materials, and energy source Safety & Effectiveness No new questions raised compared to predicate

6. FDA 510(k) Process Timeline 1 Submission Digital submission with e-copy or CD 2 Review (60-90 days) FDA evaluates substantial equivalence 3 Additional Information AI requests or RTA notices if needed 4 Clearance Device cleared for US market Re-submissions must be completed within 180 days

7. Why Choose Maven? Industry Experts Customized solutions based on client needs Timely Execution Practical approach to compliance Client-Centered Value-based, strong, and resilient team

8. Contact Us https://mavenprofserv.com/us-fda-510k/ [email protected] [email protected]