Medical device makers Medtronic Inc., Johnson & Johnson and Stryker Corp. face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.
The Food and Drug Administration released the proposed new requirements for the so-called 510(k) program that covers products similar to previously approved devices, or about 90 percent of products cleared for sale.
Medical device companies say the 510(k) process is rife with delays and inconsistent requirements, while consumer advocates say patients are at risk because of inadequate safety rules. The new proposals address both issues, giving device makers a more predictable process while insisting they provide more safety data, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
The proposals “seem to respond to many of the concerns expressed by industry about the chaotic situation they regularly encounter in trying to deal with the FDA,” Ira Loss, a senior health-policy analyst at Washington Analysis LLC in Washington, said in an interview. “They seem to have taken a reasonable approach to a difficult situation that will still need lots of time to fix.”
While the rules announced yesterday include “a number of commendable steps,” there are more than 70 changes that “taken together could result in a significant disruption to a program that has served patients well for more than 30 years,” Stephen Ubl, chief executive officer of the Advanced Medical Technology Association, a Washington-based trade group, said in a statement.
Cost of Approval
The cost of clearing a device through the existing 510(k) program may range from less than $1 million to as much as $50 million, compared with $50 million to $150 million under a more-stringent FDA program for higher-risk devices such as heart pacemakers, Linda Alexander, an industry consultant at Alquest Inc. in Minneapolis, said in an interview.
Shuren ordered a review of the program in September amid criticism from Congress and consumer groups that the agency wasn’t adequately protecting patients.
In April, he announced a “major shift” in the approach to medical device safety for infusion pumps used to administer drugs and fluids to patients. The pumps had been tied to more than 56,000 complaints of injuries, deaths and product malfunctions from 2005 to 2009, the agency said. The FDA said it would require more data about the pumps’ designs, more testing in “real life” settings similar to how the devices are used, and more reporting of data after the products go on the market.
In announcing the altered rules, Shuren said device makers will be asked for the first time to provide a complete summary of all information about the safety of their products. Data such as clinical studies relevant to a product often aren’t included in a company’s application, leading to “many follow-up questions,” he said.
“It’s mind-boggling that this information wasn’t required before” for devices, Loss said. “With drug approvals, you have to submit full safety and efficacy data” when applying for regulatory approval.
The proposals are “very industry-focused” and don’t go far enough to protect patients by requiring more stringent safety and efficacy testing of devices, said Diana Zuckerman, president of the National Research Center for Women & Families in Washington.
“We need more scientific clinical studies to make sure that people getting medical devices are better off than people who don’t get them,” Zuckerman said. “We could be spending billions of dollars on products that don’t work and aren’t safe.”
As part of the new procedures, the FDA will create a Science Council for its medical device unit to “assure quality and consistency” about “some of the tougher science questions,” Shuren said. The council, to include agency reviewers and managers, will be headed by William Maisel, a cardiologist and former director of the Medical Device Safety Institute at Harvard-affiliated Beth Israel Deaconess Medical Center in Boston.
“We look forward to evaluating the comments and welcome the opportunity to continue working with the agency to bring innovative medical technology to patients,” Brian Henry, a spokesman for Minneapolis-based Medtronic, said before the FDA publicly released the proposals.
For a device to be approved through the current 510(k) process, a manufacturer had to demonstrate it was “substantially equivalent” to a previously approved product. Under this system, the safety risk increased if that earlier device came on the market “not because it was shown to be safe and effective, but rather that it was substantially equivalent to another device,” perhaps approved many years earlier, Shuren said. Twenty-nine percent of 510(k) submissions in 2009 cited an earlier product that was no longer on the market, he said.
Shuren said a survey of agency staff found that employees didn’t agree on “substantial equivalence,” which has led to “inconsistency in decision making.” The agency proposes to clearly define the term, he said.
The agency also plans to streamline the application process for a category of devices that aren’t similar to earlier products and are deemed to have a low enough safety risk that human studies aren’t needed, Shuren said. The “de novo” process, a subject of frequent complaints by the device industry, has been plagued by “lengthy review timeframes and nontransparent data requirements,” Shuren said.
The agency expects to begin making the changes later this year after a 60-day public comment period, Shuren said.
Shuren’s broader review followed a January 2009 report by the Government Accountability Office that called for “immediate steps” to increase scrutiny of higher-risk medical devices that were cleared under the 510(k) program.
The FDA’s staff issued a report in September saying the clearance of a knee implant made by Hackensack, New Jersey-based ReGen Biologics Inc. was flawed and influenced by company lobbying and lawmakers from New Jersey. The ReGen device was cleared under the 510(k) rules.
The ReGen debate “really brought this issue to a head,” Loss said. “That’s usually what it takes to get reform; you have to have a horror show.”
The agency also asked the Institute of Medicine, part of the National Academy of Sciences, to conduct an independent evaluation of the 510(k) program. The institute held the last of three public workshops July 28 and is expected to release its report in mid-2011, which could prompt more changes, Shuren said.