The Food and Drug Administration proposed shoring up medical-device approval rules that have been criticized as lax and inconsistent by consumer advocates and the agency itself.
The FDA aims to better define what devices can use an approval pathway known as 510(k), under which companies can get an accelerated decision on whether they can market a new product if they can show it is similar to an already approved device. The proposals, which will be open for public comment, will be closely watched by the device industry because more-stringent rules would raise development costs.
The FDA's top device regulator, Jeffrey Shuren, rejected suggestions that the changes would result in fewer devices being eligible for 510(k) approval or raise the need in general for extra medical studies. He said clarity was the main point of the effort.
The FDA began reviewing its medical-device regulations in September after issuing a self-critical report that said top regulators bowed to outside political pressure when approving a ReGen Biologics Inc. knee device in 2008. Articles in The Wall Street Journal had pointed to the political pressure and other irregularities in the ReGen case. ReGen said its device was safe and effective and defended its activities before the FDA.
"There is widespread recognition that there's significant room for improvement in the way we operate," said Dr. Shuren, who directs the FDA Center for Devices and Radiological Health.
The FDA said it wants to develop guidance clarifying when older devices shouldn't be used as a benchmark, or "predicate," for comparison to a new product. The agency is still working on the guidelines, but said there appears to be confusion about the rules.
The agency also proposed creating a subset of Class II devices for which clinical or manufacturing data would be needed to bolster the case that they are substantially equivalent to an already approved product. Class II devices are generally considered to carry moderate risk to patients. Dr. Shuren said drug-infusion pumps, ubiquitous hospital products which the FDA is seeking to improve amid a history of problems, fall into this new "Class IIb" category.
Pump maker Baxter International Inc. is in the process of pulling 200,000 pumps off the U.S. market after the FDA decided it was moving too slowly to fix the devices, whose flaws have included failure to deliver the right amount of medicine.
The device industry's trade group said the proposals included a number of steps that would increase the consistency and predictability of the approval process, but as a whole threatened "significant disruption." Among the industry's complaints are an agency plan to include detailed information about new products, such as design schematics, in a public database. That would give foreign competitors access to proprietary information, potentially hurting U.S. manufacturers, said Stephen J. Ubl, president and chief executive of the Advanced Medical Technology Association.
