Support in the US FDA Market Access

IPN can assist companies with US market access through the FDA, a service that begins with the regulatory path assessment. IPN team can then help with the product code and regulation number determination, device classification (classes I, II and III), as well as in the identification of applicable standards and guidance documents. IPN also assists in the confirmation or identification of potential predicate devices, and in the identification and evaluation of performance data needed in premarket submissions.

IPN is able to prepare or review the following types of submissions:

• Q-submission,

• Pre-Request for Designation (Pre-RFD)

• 510(k) Premarket Notification

• De Novo Classification requests

• Premarket Approval (PMA) Applications

• Emergency Use Authorizations (EUA)

IPN can also aid with FDA’s Investigational Device Exemption (IDE) and other clinical studies requirements, as well as support and guidance regarding US post-market requirements.