After months of review, debate and discussion, the Food and Drug Administration on Wednesday released new guidelines governing the way most medical devices are approved by the federal agency. The reaction was fast and fierce.
The new rules drew a collective sigh of relief from the $350 billion medical technology industry, which has a considerable stronghold in Minnesota. But the activist group Public Citizen fired back that the agency cowed to industry pressure.
Dr. Jeffrey Shuren, chief of the FDA's device division, told reporters the recommendations are designed to improve transparency and predictability in the way medical devices are cleared under the agency's 510(k) process -- while ensuring products are safe and effective.
That 30-year-old clearance process requires makers of medical devices to prove a product is "substantially equivalent" to an existing one on the market -- often without clinical studies on patients to prove the device is safe and effective.
The initiative announced Wednesday "is designed to make the 510(k) process a blueprint for smarter medical device oversight, and one that drives innovation and enhances patient safety," Shuren said.
The guidelines were first proposed last year and have been closely studied by Minnesota's medical technology industry, which includes more than 300 companies, among them market leader Medtronic Inc. The industry and members of the state's congressional delegation have aggressively lobbied FDA officials for regulations they consider more conducive to innovation of new products.
The changes are part of a broader government initiative announced by President Obama on Tuesday involving a review of U.S. regulations "to remove outdated regulations that stifle job creation and make our economy less competitive."
Stephen Ubl, head of the med-tech industry group AdvaMed, called the FDA's analysis "thoughtful. ... Much of the agency's plan supports our long-standing position that the 510(k) process is fundamentally sound and has been beneficial to American patients."
Implementation of some controversial items originally proposed by the FDA was delayed until the Institute of Medicine, an independent organization that provides advice to policymakers, finishes a separate report later this year. Companies have objected to regulations that would strengthen FDA's authority to rescind approval of devices and permit the agency to require companies to conduct more safety studies once a device has been approved.
Fridley-based Medtronic said in a statement that it would support requirements for additional information on products where a higher level of concern arises about their intended use. Any additional pre- and post-market requirements should be made on a case-by-case basis, the company said.
Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the items were deferred because "the device industry did not agree with these proposals. ... The FDA is not being forceful enough about improving the safety and effectiveness of new devices."
The FDA recommendations call for a revision of the "de novo" approval process, which involves review of innovative, lower-risk devices. These products don't have a "substantially equivalent," previously cleared device and have not been marketed in the United States, but their safety profile is well known.
Changes include guidance to help companies applying for this type of clearance determine what data will be needed, including clinical trials. Another change involves more training for FDA staff.
Janet Moore • 612-673-7752
