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GUIDANCE DOCUMENT

Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Guidance for Industry and FDA Staff September 2008

Final

Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides detailed information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. This guidance replaces “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” dated September 30, 1997 (the 1997 guidance).

The 1997 guidance stated that any substantial equivalence decision should be followed by submission of a 510(k) Special Report prior to shipping the device. This new guidance document no longer recommends the submission of a 510(k) Special Report if the manufacturer maintains acoustic output measurements and labeling records in their Design History File (see Appendix A of this guidance document). Appendix A contains suggestions for documenting this information. Also refer to: CDRH Device Advice, Quality System and 21 CFR Part 820--Quality System Regulation, Subpart C--Design Controls; Sec. 820.30(j) Design History File.

This guidance also adds appendices addressing non-OEM (original equipment manufacturer) replacement transducers (Appendix B) and reprocessed “single-use only” transducers (Appendix C) and revises recommended labeling for cleaning and disinfecting transducers (Appendix D).

NOTE: This guidance refers to many voluntary standards and other guidances. An attempt has been made to list the most current versions, but submitters should refer to the latest version of guidances and voluntary standards (see individual standards documents and the CDRH web page http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm on recognized standards) when preparing their submissions. Contact the Radiological Devices Branch (RADB) if questions of applicability arise.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.