According to section 513(g) of the FD&C Act, device manufacturers may submit a written request to obtain the Agency's views regarding device classification and the regulatory requirements applicable to their device.
513(g) requests must be submitted to the FDA in writing and are appropriate in situations where the device manufacturer can't easily determine which class their device fits into and would like to confirm their decision with the FDA. These requests allow manufacturers to obtain additional feedback from the Agency and help sponsors determine the best regulatory pathway for their device.
As with any FDA submission, completing a 513(g) Request for Information is a challenging task and should be completed by a seasoned professional. The Weinberg Group can help you determine the best classification for your device, as well as assist in the development and submission of a 513(g) Request for Information. We will work with you to ensure your request is complete and contains all required information, which includes:
- Cover letter
- Description of the device
- Description of what the device is to be used for
- An investigational plan approved by an institutional review board (IRB)
- As applicable, any labeling or promotional material of a similar, legally marketed device (if available)