The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the marketing clearance and use of diagnostic ultrasound systems and transducers. This guidance document supersedes the guidance entitled “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” dated September 9, 2008.
This guidance document provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)). As before, manufacturers who submit 510(k)s and receive marketing clearance will continue to be exempt from the Electronic Product Radiation Control (EPRC) reporting requirements in 21 CFR 1002.12, for diagnostic ultrasound devices, as described in the notice to industry entitled “Exemption from Reporting under 21 CFR 1002” dated February 24, 1986.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in the FDA guidance means that something is suggested or recommended, but not required.
It guidance document includes the following:
- Recommendations on what should be included in a premarket 510(k) application for diagnostic ultrasound systems and transducers
- The kinds of modifications to a diagnostic ultrasound device for which a new premarket 510(k) application is unnecessary
- A new transducer element integrity check that applies to all the ultrasound devices covered in the guidance
Electronic comments and suggestions my be submitted online at https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2017-D-5372. Comments may not be acted upon by the Agency until the document is next revised or updated.
On August 22, 2019, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about the Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance.
Find out more about the webinar at https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-marketing-clearance-diagnostic-ultrasound-systems-and-transducers-final-guidance-august-22