Display Devices for Diagnostic Radiology, Part 2: FDA Labeling Requirements for 510(k) Submissions
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 information on the Agency’s recommendations, we have just want you’re looking for!
On Tuesday, February 9th, FDA published “Display Devices for Diagnostic Radiology,” a draft guidance to assist sponsors with the preparation of 510(k) submissions for display devices intended for use in diagnostic radiology.
In the document, FDA provides information intended to help sponsors of 510(k) submissions confirm that the label of their display device is compliant with FDA’s labeling requirements under 21 CFR Part 801.
Title 21 of the Code of Federal Regulations Part 801.109 (21 CFR 801.109) states that prescription devices are not required to provide “adequate directions for use by a lay person.” Instead, prescription devices must meet the labeling requirements as stated under 21 CFR 801.109, including a prescription use statement.
The draft guidance states that 510(k) submissions for display devices must include proposed labels, labeling, and advertisements “in sufficient detail to satisfy the requirements of 21 CFR 807.87(e).” It is recommended that sponsors also provide the Agency with clear and concise instructions for use that delineate the technological features of the device, as well as an overview of how the device is to be used. “Instructions should encourage local/institutional training programs designed to familiarize users with the features of the device and instruct users on how to use the device in a safe and effective manner.”
The Agency explains that the labeling for review workstation displays for devices indicated for mammography should include the following statement:
“Mammographic images with lossy compression must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.”
The draft guidance also states that, in addition to meeting the requirements under 21 CFR Part 801, the following should be included in the user manual for a display device:
- The Indications for Use as stated in your premarket submission;
- Warnings and precautions (and any mitigation measures);
- Overview of the device;
- Principles of operation;
- Directions for use (e.g., display controls and GUI);
- Technical specifications;
- Performance specifications (summary of physical laboratory testing);
- Cleaning information;
- Hardware/software compatibility requirements;
- Conformity to any voluntary standards; and
- Manufacturer’s contact information.
Furthermore, instructions for maintenance of the system performance should include:
- A description of personnel authorized to service the system;
- Recommended maintenance schedule;
- Calibration procedures; and
- A full description of recommended quality assurance testing (with action limits), including detailed procedures for performing these tests, if applicable, and the frequency of testing. You may use the latest recognized version of NEMA Standards XR 22 and XR 23, for designing quality assurance tests.
FDA also included three appendices within the draft guidance, regarding the areas of performance testing, device modifications, and device bundling. For additional information on these topics, view the full draft guidance.
Are you developing a medical device or seeking FDA approval for your recently developed medical device? Do you need assistance developing your FDA submission? We can help. To learn more about our services and how we can help you, contact us today.