Scandal hits CDRH
The move to overhaul the 510(k) process was set in motion almost two years ago, when whistleblowers within the FDA sent letters to members of Congress, telling of pressure from above to approve devices they thought were unsafe or unproven. Although the eight or nine people involved in the campaign were a small fraction of those at the agency, it painted a disturbing picture of a department in which device approval owed as much to political concerns, as to scientific ones. The whistle-blowing would culminate in FDA’s decision in September 2009 to fund a $1.3 million review of the 510(k) process, handled by the respected Institute of Medicine, an independent group whose 2000 report To Err Is Human led to sweeping changes in adverse event reporting.

But problems continue to crop up. This summer, the FDA was rocked by further scandal, as a former reviewer accused the agency of sacking him because he refused to approve a CT scanner for virtual colonoscopies.
An investigation into some of these complaints is being handled by the Office of the Investigator General. (It’s looking for administrative, not criminal violations. A criminal investigation by the OIG of the U.S. Department of Health and Human Services was dropped in February). And the results of IOM’s FDA investigation are due in March. What it will decide is anyone’s guess. When contacted by DOTmed News, IOM spokeswoman Christine Perrel said it would be “premature” to talk about the report before it’s released next year.

Industry fears changes could cause more delays
But the FDA is not sitting idle as it waits for the IOM’s report. It has already issued draft guidelines that some think might utterly revamp the 510(k) process.

Among the 65-odd proposed changes released this summer are some related to increased transparency, such as requiring device-makers to publish submission materials on publicly accessible databases, as well as to offer more surveillance of devices after they reach the market.

But perhaps the most notable is the creation of a Class 2b category for devices riskier than those normally cleared under Class 2 rules, and which could require clinical trials. By press time, the FDA had not clarified what devices would fall under this category, although hints dropped at meetings have worried trade groups, such as the Advanced Medical Technology Association (AdvaMed).

Although in principle AdvaMed said it supports subjecting a subset of Class 2 devices to enhanced requirements, it fears the FDA could use too broad a brush for the category. For instance, suggested criteria for making a device Class 2b could include products permanently implanted in the body. But AdvaMed points out this would include a device most agree is reasonably low risk: sutures.

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