FDA Approval

All companies planning to sell a medical device or IVD in the United States need to register their product with the US FDA. Most Class I devices can be self-registered but most Class II devices (and a small number of Class I and III devices) need to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. For Class III devices, a Pre-Market (PMA) submission is needed.

As an FDA consulting company for medical device and IVD, STEMart can help you with US FDA 510(k) submission to successfully introduce your medical devices to the US market.

What We Do

• Comprehensive documents evaluation and gap analysis prior to 510(k) submission
• Determine the proper FDA product code and regulation number according to the proposed intended use and design of your device, which may point to device-specific guidance documents or required standards.
• Evaluate and choose the similar devices with FDA 510(k) clearance to determine substantial equivalence for your device.
• Provide a list of documents and information needed for the 510(k) submission for specific product.
• Review information by an assigned U.S. regulatory consultant to determine documents suitability for the 510(k) submission.
• Prepare a detailed gap analysis report to identify incomplete or missing information required for a complete 510(k) submission.
• Dossier compilation and FDA 510(k) submission
• Prepare a technical comparison between your medical device and the predicate device(s).
• Prepare all 21 sections of the FDA 510(k) application.
• Submit the hard copy and eCopy of the 510(k) to the CDRH division within the FDA and be the correspondent for further communications with the FDA.
• Coordinate payment of FDA 510(k) submission fees on your behalf.
• Immediately communicate with you regarding all information received from the FDA following the 510(k) submission, and assist in addressing their requests for additional information, if applicable.

Why Choose Us

• In-depth knowledge of the laws & regulations;
• Full FDA documentation and support;
• Step-by-step guides for preparation of 510(k) submission.

STEMart provides cost-effective approach to assist medical device manufacturers in receiving FDA clearance of a 510(k) submission. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.