Generally, medical devices in the United States of America are classified 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 classification database. What if the SE is not found?
In case you are not able to find SE for your invention in the 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 request process must be initiated by submitting a written 513(g) application (Request for Information) to CDRH. 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 also provides Regulatory assistance in preparation and review of the application.
- Identify 513(g) requirement for the product in scope
- Preparation and review of 513(g) application
- Device classification
- Agency interaction
- Proven expertise to overcome the challenges in the process
- Local presence to support the process and interaction with agency
- Post-decision support for product approval with agency