Following the release of a controversial new report from the Institute of Medicine on how medical device are cleared for marketing, in many instances bypassing a premarket scientific review for safety, the Food and Drug Administration is calling for public input into the 510(k) clearance process.
The IOM report said the FDA should develop a new regulatory framework to replace the 35-year-old 510(k) process because it “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 510 (k) process allows medical devices to be cleared for marketing if the manufacturer claims the device is “substantially similar” to a device already on the market. Even if that “predicate” device has been recalled because of safety concerns, the devices that relied on it for approval do not have to be revisited. Since 510 (k) was established in the mid 1970’s new plastics, computer components, and materials have been developed, but many of today’s device makers still claim to be substantially similar to devices of the past. The 510 (k) process gets a product to market faster and without the costly premarket review for safety.
The IOM believes the old 510(k) should be scrapped and a new framework developed that uses premarket clearance and postmarket surveillance of medical devices to make sure they are performing as promised.
Here is the Federal Register calling for public input into 510(k).
The FDA adds in the Federal Register that this public docket does not mean it endorses the conclusions of the IOM.
Public comment must be submitted by September 30, 2011. #