FDA passes on setting new regulations for medical device servicing
November 20, 2018 Instead, the Agency found that many OEMs and third parties provided high-quality, safe and effective servicing, such as refurbishing and reselling more durable equipment including imaging machines, automated external defibrillators, endoscopes and ventilators. “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread … Read more