Exempt Devices / 513(g) Submissions

Whether you are sure the product you plan to launch without FDA clearance is an exempt device or not, call PDG®. Our consultants will assist you in the compilation of a regulatory dossier to support marketing of the product to be retained with your records in case of an FDA audit.

The Benefits of the Process for 513(g)/Exempt Devices

The 513(g) process allows a sponsor to ask questions such as whether FDA regulates a given device, if the device is exempt, or the least burdensome regulatory pathway for a device, which introduces a new technology or a new intended use. While information from the 513(g) process does not represent clearance to market, PDG will use this and other research to provide a regulatory foundation similar to a 510(k) including, for example, predicates and validated test results from the device manufacturer (stability, biocompatibility, etc.).

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