The Institute of Medicine (IOF) would say yes. In a report issued last week, the group wants the FDA to replace the 35-year-old 510(k) clearance process for medical devices saying that process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one."
The group advocates that a better investment would be a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use.
The problem with the process, according the group, is that at the 510(k) clearance does not determine a device to be safe or effective.
Whether things will change as a result of this report or not is uncertain. "I think it builds towards the continuing narrative that the healthcare landscape, particularly for medical device companies, is changing and not for the better," explains Venkat Rajan, Industry Manger, Medical Devices for Frost & Sullivan. "Increasingly it will be harder for them to get products approved and paid for with changes to reimbursement and health care cost cutting measures."
IOM said the FDA should explore whether a modified version of its de novo process could replace the 510(k) process. The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared. "Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program," the group concluded.
"Specific to the report, I don't think there was anything particularly completely revolutionary," Rajan added. "Their recommendations called for more transparency, and for a better process and set of metrics to evaluate the safety of new medical technologies regardless of their equivalency in function to existing products.
"The FDA has already come out and said while they are always looking for methods to improve their evaluation process, they do not have any current plans to scrap the FDA 510k process," said Rajan.
One of the issues particular to the U.S., Rajan, says, is that there is much simpler regulatory approval processes in Europe and abroad without major safety risks. "Companies are worried about further restrictions here which could hamper product launch cycles."
