FDA Announces Potential Overhaul to Medical Device Review Process
The FDA announced it intended to overhaul the new medical device review process with the intent to improve device safety. See the AP article at the link below for more details.
The review system, which includes the 510(k) submission and is the pathway used to clear most devices, has been in place for decades and may well need an overhaul in some capacity. The article states that the process needs improvement to keep up with technological advancements in devices. True, technology has made major advancements since the substantial equivalence pathway was adopted in 1976, but not all devices have had such rapid technological advancements. Compare a cannulated bone screw to a diabetes glucose meter and that point is clear. It may make sense to apply stricter criteria to a complex device such as one including software and electronics versus an orthopedic device where the basic technology hasn’t changed much since the original device was cleared.
It will be interesting to see how this overhaul moves forward. Typically, it has taken a long time for the FDA to make changes to practices on a much smaller scale. And this overhaul may involve congress and a long list of government and civilian officials. I certainly hope that if this moves forward, they group devices based on technology or application or complexity for different pathways, rather than making the clearance pathways more strict for all devices. The industry absolutely needs to be dedicated to providing safer devices, but that also has to be balanced with getting those safe devices to market in a reasonable time.