FDA recommends new 510(k) submission process for ultrasound vendors. Image Source: Nottingham University Hospitals

The FDA has released a new guidance providing information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers.

The guidance replaces “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” that was released Sept. 30, 1997.

According to agency, the new guidance 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.” 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.

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