- August 22, 2019
01:00 PM - 02:30 PM EDT
- Organized By:
Summary: On Thursday August 22, 2019, the FDA hosted a webinar for device manufacturers and industry to discuss and answer questions about the Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance.
Background: 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.