FDA 513(g) Submission

The United States Food and Drug Administration (US FDA)'s 513(g) process is crucial for manufacturers seeking clarity on their medical device classification and Regulatory pathways. Freyr, with its expertise in handling 513(g) submissions, assists you in identifying the need for a request, prepares and reviews your application, and provides you with Regulatory support throughout the process, ensuring that you are able to seamlessly navigate the US FDA's Regulatory landscape.

FDA 513(g) submission Overview

The US FDA's medical device classification system in the United States of America predominantly depends on a predicate system for classifying medical devices. That is, drawing comparisons to legally marketed devices and determining the classification of I, II, or III based on the risk. To enable manufacturers, to determine the classification of their devices or to search for Substantially Equivalent (SE) of their devices, FDA provides a Medical Device classification database. In cases where the SE is not found, manufacturers can explore alternative options by submitting an FDA 513(g) Submission to obtain the agency's recommendations on the device's classification and applicable regulatory requirements. The FDA 513(g) request serves as a valuable tool for manufacturers seeking clarity and guidance on the regulatory pathway for their medical devices.

If you are not able to find SE for your invention in the US FDA Medical Device classification database, to obtain the agency’s recommendations on the class of the device, In Section 513(g) under the Federal Food, Drug, and Cosmetic (FD&C) Act US FDA provided the procedure for requesting information. The 513(g) request for classification must be initiated by submitting a written 513(g) application (Request for Information) to CDRH. Submitting the 513(g) application acts as a means to obtain the agency’s insights regarding the classification and the regulatory requirements that may be applicable to your specific device. An FDA 513(g) submission should include the following:

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

Upon receipt of the 513(g) request, FDA will evaluate the information and revert within 60 days, providing information on how you should classify your product with a product code and an applicable regulation number.

A 513(g) application decision is limited to offering suggestions on the probable class of the device, thereby excluding the following considerations.

  • 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 the preparation and review of the 513(g) application.

FDA 513(g) Submission Expertise and Advantages

  • Identify the FDA 513(g) submission requirements for the product in scope.
  • Preparation and review of FDA 513(g) application.  
  • Device classification.
  • Agency interaction.
  • Proven expertise to overcome the challenges in the FDA 513(g) Submission process.
  • Local presence to support the FDA 513(g) process and interaction with the agency.
  • Post-decision support for product approval with the agency.