The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has issued recommendations for medical device manufacturers seeking marketing clearance for diagnostic ultrasound systems and transducers.
Contained in a guidance issued in late June, the recommendations describe the types of modifications to a diagnostic ultrasound device for which the FDA does not intend to enforce new premarket notification 510(k) requirements. Section 5.1.2 of the guidance (“Compliance Policy”) describes in extensive detail ten separate criteria that must apply to a modified device to eliminate the requirement for filing a new premarket notification. Those criteria include:
- The intended use of the modified device is not changed;
- The device is not a reusable device;
- The modes of operation for the modified device are well-established
- The modifications do not lead to acoustic outputs that exceed the recommended maximum levels;
- The modifications do not result in a range of ultrasound interrogation parameters outside a well-known range;
- The modifications do not utilize novel mechanical or thermal effects for imaging or measurements;
- The measurements and analyses are clearly described and control parameters are user adjustable;
- A transducer element check is performed;
- Transducer surface temperature falls within a well-defined range; and
- Appropriate transducer covers are recommended to users.
Guidance documents are informative and are issued only to describe the current thinking of a federal agency in connection with certain regulatory issues. As such, they do not have the force of law and are not binding either on the agency or the public.
Read the FDA’s guidance on the market clearance of diagnostic ultrasound systems.
