In July, the US Food and Drug Administration (FDA) issued a draft guidance for clinical investigations of prostate tissue ablation devices including focused ultrasound systems. The Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) are in favor of such guidelines yet suggest the need for some fine-tuning for the final guidance.
In an article posted on the Regulatory Affairs Professionals Society website, the groups agreed that new focused ultrasound products to treat the prostate will be introduced in the coming years, and guidelines to inform proper clinical investigations will be necessary. However, AdvaMed and MITA suggested some changes to the guidance document’s requirements for specific effectiveness endpoints, and MITA also had concerns about internally controlled trials.
AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world.
MITA is a division of the National Electrical Manufacturers Association (NEMA) and is the leading organization and collective voice of medical imaging equipment, radiopharmaceutical manufacturers, innovators and product developers. In April 2018, the Foundation entered a formal partnership with MITA to raise awareness of focused ultrasound technology among policymakers, payers, and medical specialty societies.