On February 9, 2016, the FDA published a draft guidance entitled “Display Devices for Diagnostic Radiology.” The document, which will replace a 2008 guidance (“Display Accessories for Full-Field Digital Mammography Systems – Premarket Notification (510(k)) Submissions”), outlines what information should be included in 510(k) submissions for display devices used in diagnostic radiology.
Display devices, also referred to as soft-copy displays or medical grade monitors, “are used to display, store, transfer, or process medical images and are commonly used by radiologists to make diagnoses,” as defined by RAPS. These devices use LCD and LED technology to display images, which are then enhanced and analyzed using communication and storage hardware and software.
Display devices for diagnostic radiology are classified by the FDA “as class II devices that are intended to use used in controlled viewing conditions to display and view digital images for primary image interpretation.” Typically, 510(k) submissions for display devices are separate from those of other image acquisition or management devices. “However, this guidance may apply when displays intended for diagnostic interpretation classified under 892.2050 (product code, PGY) are included as part of a 510(k) submission along with other software and/or hardware.”
The draft guidance provides a number of recommendations regarding the description of the device that is included in the submission. The Agency requires sponsors to provide information that shows how the device is substantially equivalent (SE) to a predicate device in their submission, and advises that they include the following information:
The IFU should clearly state whether or not the device is intended for mammography. If the device is intended for mammography, the IFU should address how the device will be used, such as:
An example of the IFU for devices not indicated for mammography is:
A complete description of the device should be provided in the 510(k), including the following information:
In addition to the items listed above, the guidance provides the following recommendations regarding the contents of 510(k) submissions for display devices:
FDA recommends that the electrical safety of devices be evaluated according to the most recent FDA recognized standards contained within FDA’s Recognized Consensus Standards Database.
The 510(k) should include documentation for the software and firmware that has been developed for use with the device in question. The type of information that should be submitted is determined based on the risks associated with a potential software failure by the device.
“Display devices intended for diagnostic radiology may include firmware and software for the following functionalities:
The Agency recommends that sponsors provide data for a variety of performance tests, along with a side-by-side comparison of the same data for the predicate device.
For additional information, view the FDA’s full draft guidance.
Are you in the process of developing a medical device? Do you have a device that needs FDA approval? We can help. Using our proprietary approach, we can help get your product through FDA cheaper, better, and faster. To learn more about our services and how we can help you, contact us today.
February 11, 2016
Last week, we provided you with details on FDA’s recommendations for describing display devices in 510(k) premarket submissions. Did we leave you wanting more? Well if you were wishing for additional...
February 11, 2016
On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...
February 11, 2016
On February 18, 2016, the FDA issued a final order which will require the submission of premarket approval (PMA) applications for metal-on-metal (MoM) total hip replacement devices, which are hip...