The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will substantially reduce the administrative burdens for itself and the medical device industry.
Following a public consultation, FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation protection during medical procedures. It also does the same for certain records and reporting requirements for electronic products and performance standards for diagnostic x-ray systems and their major components, lasers and ultrasonic therapy products. The agency said the move is meant to reduce regulatory requirements that are outdated and duplicative…
