The FDA released a new draft guidance today that details information medical device makers should include when submitting 510(k)s for display devices to be used in diagnostic radiology.
The guidance begins with basics: premarket notifications should identify the device by regulation and product code, and information should be provided that shows how it is “substantially equivalent” to an approved device.
According to the guidance, there should also be an Indications for Use (IFU) statement, which describes the diseases or conditions the device will be used to diagnose. The intended patient population should also be specified.
The IFU should also be used to state if the device is or is not intended for use in mammography. Examples of potential IFU statements provided by the FDA are, “The _____ is indicated for use in displaying radiological images (including 191 mammography) for review, analysis, and diagnosis by trained medical practitioners.” and, “The _____ is indicated for use in displaying radiological images for review, analysis, 196 and diagnosis by trained medical practitioners. The display is not intended for 197 mammography.”
The FDA also recommends that a complete description of the device be included in the 510(k). This includes information about the device’s display technology, screen size, frame rate/refresh rate, touchscreen capabilities, and more.
In addition, there are some specific points the FDA suggests companies explain along with the description.
“The 510(k) submission should include a discussion of any differences in the technological characteristics between your device and the predicate device with additional information necessary to determine whether the differences raise new questions regarding the safety or effectiveness of the new device,” the guidance read. “Additional discussion in paragraph form is recommended for novel features.”
The draft guidance also includes sections on describing software and firmware that works with the device, listing all applicable testing data, and how to meet the FDA’s labeling requirements.
“We recommend you submit clear and concise instructions for use that delineate the technological features of your device and how your device is to be used,” the guidance read. “Instructions should encourage local/institutional training programs designed to familiarize users with the features of your device and instruct users on how to use your device in a safe and effective manner.”
Labeling should also include a mammography statement, much like the IFU.
This new draft guidance can be read in full on the FDA’s website. Once final, the document will replace a guidance from May 2008.
The FDA will accept public comments and suggestions about this draft guidance for 90 days after notice has been published in the Federal Register. Comments and suggestions can be sent electronically to www.regulations.gov or mailed to the FDA’s dockets management division in Rockville, Md.