FDA to change 510(k) process 25 ways

The FDA has identified the areas where it will make changes, but details of those changes will come one at a time based on a schedule the FDA laid out in its 2011 action plan. The agency will take public comment on the guidelines as they are issued.

“The critical next step is how FDA implements the plan," said Ubl of AdvaMed. "Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.

“We look forward to working with the agency to address the full spectrum of issues that have contributed to unacceptable delays and inconsistency in the review process," he added.

Eleven of the changes in the FDA's action plan focus on regulatory issues for device makers. Two of the most controversial of these reforms involve creating online databases of pictures of devices under FDA review and of device labels that spell out intended uses of those products.

The FDA said it will conduct public meetings April 7-8 to get feedback on how much information should be made public and what should remain private to the companies. "Those proposals raised a lot of questions for industry about what is needed and how to guard proprietary information," said Alpert of Medtronic.

Eight changes are aimed at ways the FDA will provide better guidance, and five describe internal changes at the FDA such as setting up a Science Council to continuously review new science and the 510(k) process.

The agency pledged to put in place by mid-July a process to identify its staffing needs and recruit and train staff. Industry observers have complained the slowdown of the regulatory process is due in part to high turnover among FDA examiners.

The FDA pledged to release September draft guidance on how it will simplify the so-called de novo process for identifying Class III products which represent the lowest patient risks. At that time it will also issue guidelines on when its needs clinical data, schematics and product pictures to support 510(k) applications.

In September 2009, the FDA started an internal review of the 510(k) program and asked the IOM to conduct its own independent review. The moves were sparked in part by a public controversy when a group of examiners complained to Congress FDA management overruled their decision to reject a 510(k) application.

At that time health care professionals said the program wasn't strict enough while industry complained it was "unpredictable, inconsistent and opaque," the FDA said in a press statement. The FDA received 76 written comments on the original 55 recommendations for changing the 510(k) program.

As many as three-quarters of venture capitalists are leaving the health care sector due to regulatory delays in the U.S., and device companies are increasingly turning to Europe as their first market, executives said at an industry event in September.