Certifications

For your information, the U.S. FDA’s new policy is quoted below:

“These transducers are generally those that are manufactured by a party other than the original equipment manufacturer (OEM) and are intended to replace a transducer originally provided by the system manufacturer.  They can be either new transducers or original equipment transducers that have been modified or remanufactured.  A new 510(k) premarket notification should be submitted for all non-OEM transducers.………………………………………………………………………………………………………………………………….”

--Draft version of Appendix A in “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers”, Issued by FDA, U.S.A.