FDA 510(k) Submission for Medical Devices

FDA Medical Device Approval Process

See a flow chart that clearly explains the FDA 510(k) application process step by step. Learn more about how the US FDA reviews 510(k) applications and how long it takes to obtain FDA approval (clearance).

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Does Your Device Require a 510(k)?

Want to know if your product requires a 510(k) submission? Learn how to determine your FDA medical device classification, Product Code, FDA Regulation Number and how to search for predicate devices already cleared for sale by the FDA.

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Overview of FDA Review Fees and Costs

Overview of US FDA fees for reviewing a 510(k) application and the factors we consider in determining the cost to prepare a 510(k) for your medical device.

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Sections of the FDA 510(k) Application

Learn more about the components of a 510(k) application and whether they apply to your medical device, plus the different types of FDA 510(k) submissions: Traditional, Abbreviated and Special.

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Need FDA 510(k) clearance for a new medical device? Not sure if your product requires a 510(k)? We can help. Emergo Group prepares US FDA Premarket Notification applications for a wide range of medical products from surgical gloves (which require a 510k) to complex PACS imaging equipment. Our experience with thousands of medical devices means we help you obtain FDA 510(k) clearance quickly so you can start selling your medical device sooner. Read about why you should hire an experienced 510(k) consultant like Emergo Group to complete your submission to the FDA.

In addition to our FDA 510(k) “approval” consulting services, we offer a wide range of medical device QA and RA consulting services related to the US, Canada, Mexico, China, Japan, Europe, Russia and Australia.