According to FDA requirements, new drug listings are subject to clinical trials to demonstrate safety and effectiveness.In the case of medical device approval, most simply indicate that it is similar to existing products.Truly innovative medical devices must undergo more rigorous clinical testing.
The report comes at a time when the FDA is responding to a wave of skepticism from medical manufacturers.The industry said that the FDA approval process of medical equipment has been slow and bureaucratic, virtually pushed up the cost of medical equipment manufacturers, forcing some producers out of the field, not long ago, Johnson &johnson quit drug-eluting stent market is a great example.Over the past year, medical device makers have submitted their views to the U.S. congress, where lawmakers have questioned the FDA's approval process for medical devices.
However, members of the IOM team, mostly doctors and researchers, have sided with the FDA this time.For years, the FDA has insisted that medical devices used for treatment and testing must undergo actual medical tests.
The F.D.A. sought the panel's recommendation because it intended to revise the system for approval of U.S. medical devices.The 510(k) approval system was established by the U.S. congress in 1976. If the newly developed medical device of the manufacturer is similar to the listed product, the approval system will be eligible for rapid approval.Initially, the approval path plan was used as a temporary solution for older products that have been on the market for years.Now it has become a standard approval tool for medical implants.
The IOM, which typically advises on improvements or revisions to government programmes, has been surprised that the panel said the 510(k) approval system was "flawed" and should be abolished altogether.
Expert team leader, former vice President of health affairs at the university of Florida, said David Challoner established 35 years ago, the examination and approval system has not been able to really evaluate effectiveness and safety of medical apparatus and instruments, "the next 35 years, the FDA needs to take a different approach to deal with new world: new technology, new material and new data."
The panel recommends that the FDA develop new approval systems based on safety indicators and track the failure rate of medical devices.Better tracking of complications from medical devices to replace pre-sale trials.
The panel of experts stressed the safety of the medical devices sold through the 510(k) system, which was used to approve the system, and did not guarantee doctors and patients.