The 513(g)-information request allows a medical device manufacturer to ask the FDA how a particular device should be classified if they are unsure. To do this, the manufacturer submits relevant documents to the FDA as part of the 513(g) request and usually receives a response within about 60 days. The components of such a request may include:
- A cover letter with the date of the request, the product name, a specific question, the name of the requester and contact information.
- A product description with all relevant information, such as a list of materials used, photos and sketches, samples, a summary of the product's operating mechanisms, information on energy requirements, a description of similar products already on the US market, information on labelling, packaging, and instructions for use for the product in question or a similar product already in circulation.
Of course, it is helpful to submit the request with correctly completed documents to speed up the process. Correct classification is crucial if the product is to be successfully introduced into the US market. We are happy to assist you in this and other areas upon request. Please do not hesitate to contact us.
