Recently, JAMA study highlighted a crucial point of argument to the 21st Century Cures Act. According to the study, the high-risk medical applications and devices are still in debate, as they might not undergo suitable regulatory screening procedures, before and after they are approved.
The act debates that if drugs and medical devices are approved quickly, the number of sick patients benefiting will increase in no time. Critics says that quick approvals would lead to easy entry of potentially harmful medical devices and products in the medical device market. The JAMA study was led by Joseph Ross, the public health researcher at Yale University. Ross clearly wrote to MedCity News that further reductions in the requirements of premarket as per 21st Century Cures Act will weaken the existing incentives. Critics also state that clinical studies, which lead to quick approval of medical devices and drugs lack adequate care and can also lead to bias.
Ross stated that medical devices, which possess high risks are being approved as per single pivotal trial and these devices have clear weaknesses. On an average, the high risk medical device trials studies around 250 patients and their follow-up capacity is only for one year. Ross further added that the debates for reducing all pre-market clinical trials are coupled with plans for enhanced post-market study.
28 high risk medical devices were mentioned in the study, which were approved and accepted in 2010. On an average, every high risk medical device was tested and examined only twice, before they were stamped with FDA approvals. As per Ross, it is imperative to gather accurate information about the medical devices as soon as they are introduced in the market. Ross stated that there should be a better way to collect relevant information about newly introduced medical devices before using them.