The US Food and Drug Administration (FDA) has issued final guidance for manufacturers seeking 510(k) clearance for diagnostic ultrasound systems and probes. The guidance, which replaces draft guidance published in October 2017, recommends regulatory approaches for diagnostic ultrasound systems.
FDA explains that: “This final guidance provides recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. The guidance covers key aspects of ultrasound safety, including use of consensus standards, to measure and report acoustic output, and the safety principle of ALARA (As Low As Reasonably Achievable) to continue to promote the safe use of ultrasonic imaging. This guidance describes the types of modifications to a diagnostic ultrasound device for which the FDA does not intend to enforce the requirement for a new premarket notification (510(k)) submission.”
This guidance is intended to encourage ultrasound manufacturers to add clinically useful modifications to their devices. For manufacturers with an established track record of ultrasound device development, based on the submission of 510(k)s for their original devices, this can be done for certain modifications without submitting another 510(k), as the safety and effectiveness of those types of low-risk modifications is known.
Depending on whether or not the system conforms to the Output Display Standard in IEC 60601-2-37:2015, Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, the manufacturer is advised to follow one of two regulatory ‘tracks’. Recommended contents of a 510(k) submission for a diagnostic ultrasound system are also provided.
On Thursday August 22, 2019, FDA will host a webinar for device manufacturers to discuss and answer questions about the final guidance.