This article explains what a 513g request for information is for, how to prepare a 513g request, and when to submit the request to the FDA.
What is a 513g?
A “513g” is a request for classification information from the FDA. The reference is to a section of the Food, Drug & Cosmetic Act. The purpose of the submission is to ask the FDA what product classification would be most appropriate for your device and what the appropriate regulatory pathway will be. The FDA is required by the regulation to provide a written response within 60 days of receiving the 513g request. The submission also requires payment of an FDA user fee that is eligible for a small business discount.
In a 2015 blog case study, I explained why I feel that the submission of a 513g request for information from the FDA is usually a waste of money. Since that time, our firm has prepared only a few 513g requests. There are a few good reasons for submitting a 513g request. For example, if you are developing a device that might be considered exempt under the 21st Century Cures Act as a general wellness product, your firm might submit a 513g request to verify that premarket notification is not required for your device.
When should a 513g request for information be submitted?
Usually, device companies ask me if I think they should submit a 513g or a pre-submission request to answer questions about the testing requirements. Often the device has a known product classification code requiring a 510(k) submission. Sometimes, there will even be a Special Controls Guidance document available for the product classification. In these situations, a 513g is entirely unnecessary. I can understand the difficulties that people experience when trying to navigate the FDA product classification database because the database does not use modern natural language search algorithms like Google. However, a greater concern is that most companies are asking this question after they have already started the development of their device, and just before they plan to initiate design verification testing. This is very late in the design process–even a little late to be conducting a pre-submission request. Your 513g submission should be during the beginning of your design project (i.e., during the concept or feasibility phases of design) to verify the regulatory pathway.
How to prepare a 513g
For any device submission, including a 513g, you need to prepare a detailed device description for the FDA. Many companies find this difficult. Therefore, we provide a template for the device description. For our 513g templates, we simplified the device description we use for a pre-submission request. We also identified the required sections with an asterisk. The resulting template is shorter and easier to complete.
In addition to the device description, we recommend that you include a copy of the draft labeling and instructions for use (IFU) with each device submission. A pre-submission does not require draft labeling, but a 513g classification request does require draft labeling to ensure the FDA understands your intended use for the device. Therefore, we provide templates for companies to prepare these drafts.
The last important piece of your 513g classification request is your cover letter. The most important parts of the cover letter, are the questions you ask the FDA about your device. We provide some typical questions that would be asked in a 513g submission, but you will probably have one or more unique questions you want to ask, which are specific to your device and indications for use.
If you need to submit a 513g classification request, you can learn more about FDA content requirements by watching our 513g request webinar. If you complete our subscription form for the webinar, you will also receive access to our complete set of 513g templates. The templates for the device description, draft label, and draft instructions for use (IFU) are also the three templates we provide to new clients that will be submitting a pre-submission meeting request, a 510k submission, or a De Novo Classification Request.