513(g) Submission

Overview

Generally, Medical Devices classification in the United States of America is carried out according to a predicate system. That is, drawing comparisons to legally marketed devices and determining classification of I, II, or III based on the risk. To enable manufacturers, determine the classification of their device or to search for Substantially Equivalent (SE) of their devices, FDA provides a Medical Device classification database. What if the SE is not found?

In case you are not able to find SE for your invention in the Medical Device classification database, to obtain the agency’s recommendations on the class of the device, US FDA has a procedure for Requests for Information in Section 513(g) under the Federal Food, Drug, and Cosmetic (FD&C) Act. The 513(g)-request process must be initiated by submitting a written 513(g) application (Request for Information) to CDRH. Submitting 513(g) acts as a means to obtain the agency’s views about the classification and the regulatory requirements which may be applicable to your particular device. A 513(g) submission should contain:

• Characteristics of your device for which there is no information in classification database
• Fundamental reasons to why you believe the device falls into specific class

Once the 513(g) received, FDA will evaluate the information and revert within 60 days, providing information on how you should classify your product with a product code and suitable regulation number.

A 513(g) application decision limits to the suggestion on the probable class of the device, hence it excludes following:

• review of data related to substantial equivalence or safety and effectiveness of the product 
• confirmatory note on device classification
• FDA clearance or approval for marketing
• address the specific types of nonclinical, animal, or clinical testing appropriate to support clearance or approval of a marketing application
   

With expertise in handling 513(g) Submission, Freyr helps identify the requirement of request for information and provides Regulatory assistance in preparation and review of the application.