Posted 02 September 2016
By Michael Mezher
The US Food and Drug Administration (FDA) has issued new guidance on submitting 510(k)s for x-rays, giving device makers more leeway on the information required to demonstrate substantial equivalence to an already approved product.
The guidance, Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, replaces the agency's 1999 guidance of the same name.
In some cases, FDA says that "nonclinical information may be sufficient to support the substantial equivalence of a subject to a predicate device for many types of modifications without the need to provide additional clinical data."
Specifically, FDA says companies might not need to submit clinical data for changes to the dimensions of the device's image receptor, pixel size and resolution, or a change in its wireless functionality. If in doubt, FDA says manufacturers should seek the agency's advice through its pre-submission program.
The guidance also gives device makers a new option for the type of clinical information sponsors can submit to the agency when nonclinical information alone is not sufficient for establishing substantial equivalence.
Like the 1999 version, sponsors can also submit data from a concurrence study comparing at least 30 pairs of clinical images taken by the device and an already cleared device. As in the previous version of the guidance, FDA says sponsors should include images for each region of the body the device will be indicated for.
However, sponsors now have the option to avoid comparing a device's images to a predicate device by having a qualified expert evaluate the images produced by their device. FDA says that sponsors taking this route may be able to get by with fewer images "if the set of images can sufficiently demonstrate the range of capability of the system for the intended anatomical region(s)."
According to FDA, "A qualified expert is a US board certified (or equivalent) radiologist or a US board certified (or equivalent) subspecialty physician or dentist experienced in imaging related to the device's intended use. We recommend that the physician has at least five years of experience following residency and fellowship."