MITA backs proposed device regulation consistency

The Medical Imaging and Technology Alliance (MITA) is applauding bipartisan legislation in the U.S. Congress that would extend oversight of medical device servicing to third-party vendors.

Currently, the U.S. Food and Drug Administration (FDA) regulates only medical device service performed by an OEM.

The bill (HR 2118), introduced by U.S. Reps. Ryan Costello (R-PA) and Scott Peters (D-CA), is titled "Ensuring Patient Safety through Accountable Medical Device Servicing." It proposes FDA oversight and minimum quality and safety requirements for service performed by both OEMs and third-party vendors.

MITA cited a survey conducted by KRC Research in 2016 that found the majority of Americans believe proper servicing and maintenance of all medical and radiation-emitting devices are crucial to protecting patients. Respondents also concurred that FDA should extend regulatory oversight, including minimum quality, safety, and regulatory requirements, to all entities servicing medical devices.

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