In order for a medical device to be sold in the U.S. market many of medical devices (most Class 2, some Class 1 and 3) are subject to FDA clearance called 510(k) submission process. A 510(k) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is substantially equivalent, to an already marketed device in U.S. The 510(k) submission must compare the device to at least one legally marketed devices and provide support for their substantial equivalency claims.
As a device manufacturer or distributer you may carry the uncharted scientific material necessary for 510(k) submission. However, IRAOmega will assist you with 510(k) filling preparation to ensure all required FDA formats and necessary elements are fulfilled and are FDA compliant before submitting the 510(k) on your behalf. Click the start button for 510(k) submission assistance.
Timeline of Communication during 510(k) Review
Service & Fees:
- Review of the Device Classifications and Device Labeling
- Preparations of FDA 510(k) formats, and required elements
- Submission of FDA 510(k),10,000-14,000 USD
- FDA fee payment on Your Behalf, Free
- Communications with FDA, Free