FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)

Commercializing your medical device or IVD in the US market requires submitting registration applications to the US Food and Drug Administration (FDA). The content of your FDA submission depends largely on how your medical device or IVD is classified according to the agency’s classification scheme. Class I, Class II and Class III categories can entail different FDA registration requirements for medical devices. Here is a brief overview.

FDA submission requirements for medical devices

• If your product falls under the Class I category, you most likely do not have to obtain FDA approval or clearance. However, you must still meet Class I FDA product registration requirements.
• If your product falls under the Class II category, you will most likely need to prepare a 510(k) submission in order to satisfy FDA device registration requirements. Your FDA 510(k) filing may or may not have to include clinical data depending on the nature of your device.
• If your product is a Class III device, your FDA submission consists of a Pre-Sub (Pre-IDE) and IDE consulting.

In instances where a medical device is difficult to classify due to new technology and intended use, Emergo can conduct a formal classification request known as a 513(g) submission to the FDA on your behalf. Once the FDA confirms or determines the classification of your device, we can proceed with your FDA submission. For a detailed look at the approval process, download our free FDA regulatory chart.

Please contact us for more information on our FDA approval services for medical device manufacturers.

Additional services for United States:

• Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
• FDA 510(k) Submission Consulting and Approval
• FDA eMDR Adverse Event Reporting for Medical Device Companies
• FDA QSR Consulting
• FDA US Agent Medical Devices in USA
• FDA認証（許可）取得のためのFDA 510(k)申請
• Human Factors Engineering (HFE) and Usability Testing for Medical Devices
• US FDA Consulting for Medical Device and IVD Manufacturers
• US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
• US FDA Medical Device Classification System
• US FDA Medical Device Establishment Registration
• US FDA Official Correspondent for Medical Device Companies
• US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices