The Food and Drug Administration (FDA) has said it may tighten the approval process for medical devices as there are concerns about industry overusing quick approvals, according to an internal agency memo seen by The Wall Street Journal.
According to the memo the FDA has concerns about the increasing use of private companies hired by device makers to pre-review products. In some cases FDA approvals are conducted based on third-party validation without further scrutiny.
The FDA began a review of device approvals in autumn 2009 after a ReGen Biologics device, a knee implant called Menaflex, was approved in late 2008 using the 510(k) process, despite many expert objections.
The device had been approved over the objections of half a dozen FDA scientists and managers during a four-year battle, under the fast-track 510(k) process designed for similar products to earlier devices, known as predicate devices.
In the memo, the FDA questioned how much leverage the agency has under existing law to demand more data from companies that use the 510(k) process.