The goals of the (pdf) new guidelines are to support innovation, keep jobs in the U.S. and quickly bring safe and effective new innovative medical devices to patients, according to a statement from the FDA.
Changes to the 510(k) program require a delicate balancing act by the FDA. On one hand, industry has argued that the 510(k) process is “unpredictable, inconsistent and opaque,” according to the agency. To the contrary, consumers and health care professionals have argued that the agency’s review process for devices isn’t robust enough.
On some of the tough decisions, the FDA essentially punted, asking the Institutes of Medicine (IOM) to study the corresponding proposals further. The Wall Street Journal called the move to table some proposals a concession to the device industry.
Most lower-risk medical devices — such as imaging technology and catheters — that go on the market in the U.S. are cleared through the 510(k) program. Generally, a 510(k) application must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.
Among the key changes the FDA plans to make are:
- Streamlining the “de novo” review process for certain lower-risk medical devices
- Clarifying when clinical data should be submitted in a premarket submission
- Establishing a new council of senior FDA experts to assure timely and consistent science-based decision making
- Making device photographs available in a public database without disclosing proprietary information
- Implenting “notice-to-industry” letters that to inform the industry of when the FDA has changed regulatory expectations on the basis of new scientific evidence
The FDA plans to implement most of the proposals throughout 2011, but it has sent seven of the recommendations to the IOM for feedback, because those seven proposals raised “significant concerns” when subject to public comment last year, the FDA said. Those include:
- Defining the FDA’s authority to rescind devices that have previously received clearance
- Clarifying when a previously cleared device can no longer be used as a “predicate”
- Establishing a new class of devices, called “IIb,” that would require clinical data submissions
About 3,000 devices are cleared each year under the 510(k) program, according to the FDA. More than 90 percent of device approvals between 2003 and 2007 came through the 510(k) program, Bloomberg reported. The program was created in 1976.
“By increasing the predictability, reliability, and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices,” wrote Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in (pdf) a letter explaining the changes to consumers.
The FDA unveiled a draft of the proposed changes last year, which prompted a medical device trade group to warn that some of the new rules could result in a “significant disruption” to the industry. However that group — the Advanced Medical Technology Association (AdvaMed) — greeted Wednesday’s announcement as “a step in the right direction.”
“The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process,” AdvaMed said in a statement.
“The critical next step is how FDA implements the plan through guidances and regulations,” AdvaMed continued.
The general consensus in the industry seems to be that the proposed changes aren’t nearly as heavy-handed as many device executives previously anticipated. “We continue to believe that the FDA’s work plan will be less onerous for the industry than many feared last year,” a Wells Fargo Securities medical technology analyst said, according to Bloomberg.
Consumer advocates, not surprisingly, were less pleased. Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA’s apparent concessions mean that “industry lobbyists won, and the public lost,” the Associated Press reported.
“Today’s FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments,” Zuckerman said.
The move to change the 510(k) program comes on the heels of a report from consulting firm PwC that warned that the U.S. is quickly losing ground to emerging markets in medical technology innovation.