In Wednesday’s final version of US Food and Drug Administration (FDA) guidance on the clearance of diagnostic ultrasound systems and transducers, FDA’s Center for Devices and Radiological Health (CDRH) followed industry requests for greater clarity and addressed legislative updates.
The final guidance is largely similar to the October 2017 draft version
. Updates offered clarity in terms of using acoustic output and new uses of approved contrast agents. A new section also interpreted the FDA Reauthorization Act
’s (FDARA) support for medical imaging innovation.
Submitters can propose new uses of approved contrast agents different from those listed in approved drug labeling, per FDARA section 706. The final guidance now clarifies that submitters can propose such new uses of contrast agents, including different routes of drug administration or patient populations, among others, “as long as FDA determines that the differences do not adversely affect the safety and effectiveness of the contrast agent when used with the device.”
CDRH recognized “acoustic output beyond pre-amendments acoustic output exposure levels may be warranted under certain conditions.” It recommended pre-submissions for both other acoustic output and new uses of contrast agents, coinciding with CDRH’s Q-submission program expansion
. “Sponsors interested in pursuing new uses of an approved contrast agent are strongly urged to submit a pre-submission to discuss the potential application with FDA.”
CDRH’s recommendations are intended to support 510(k) clearances of new or modified diagnostic ultrasound systems and transducers based on a 2008 two-track approach, which divided what 510(k) information to include based on whether the device conforms to the FDA-recognized International Electrotechnical Commission (IEC) standard: IEC 60601-2-37.
Updates to the guidance are consistent with the Medical Imaging and Technology Alliance’s (MITA) January 2018 letter supporting an update to the 2008 policies. MITA executive director Patrick Hope cautioned that the list of well-established ultrasound modes of operation “risks creating confusion for the industry.” The final guidance took up Hope’s recommendation and clarified which modifications would not be 510(k)-exempt.
CDRH also added new information—stemming from Hope’s language—regarding general safety and effectiveness policies on transducer element checks, repair and maintenance of diagnostic ultrasound systems and transducers and non-original equipment manufacturers.
Per Hope’s feedback, the final guidance stresses that the transducer performance test “should be accessible by competent technical personnel” and the integrated test feature “should also be available to the operators to initiate any time when a particular probe is suspected of failure.” He also requested the added language that “all patient contact materials that are changed during the remanufacturing process should be tested for biocompatibility” and that manufacturers should provide information and instructions to their users regarding repair and maintenance.
Another update made based on feedback placed more emphasis on the role of IEC 62359 edition 2.1.
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff