Mend it, don’t end it.
That’s what some members of the medical device industry in Orange County are saying about the Food and Drug Administration’s 510(k) regulatory program for approving products similar to those already on the market.
The program generally applies to devices featuring what are considered incremental improvements on existing products. Going through the process can cost device makers less than $1 million in some cases and up to $50 million.
The program is used to evaluate 3,500 to 4,000 medical device applications a year, or a majority of all submitted.
The consensus on the program’s fate is shaping up in the wake of a report issued by the Institute of Medicine and commissioned by the FDA.
The institute, part of the National Academy of Sciences, said the 510(k) program “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk (medical) devices and cannot be transformed into one.”
An institute committee argued that FDA’s “finite resources” would be better invested in developing a new regulatory framework that would use both premarket clearance and improved post-market follow up on devices’ performance to provide “reasonable assurance of the safety and effectiveness.”
The FDA said it won’t dismantle 510(k) despite the recommendation of the report, which came out last month.
The institute’s report isn’t binding, and FDA officials are still taking public comments while considering how much of an overhaul the program might see.
Having the institute review the program allowed an “independent third party” to weigh in on the matter, according to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, which oversees the 510(k) program and spent $1.3 million for the report.
Some industry executives took issue with the institute’s findings.
“I would say the recent report really failed to put forth any specific recommendations to improve the (review),” said James Mazzo, president of Abbott Medical Optics Inc., a Santa Ana unit of Abbott Laboratories that makes medical devices used in cataract and laser vision correction surgeries.
Mazzo chairs the board of the Washington, D.C.-based Advanced Medical Technology Association, also known as AdvaMed.
“We don’t find any sound judgment” behind the institute’s recommendation to dismantle 510(k), he said.
Many of Abbott Medical’s surgical devices are cleared through 510(k). Its intraocular lenses that are implanted in the eye undergo a more stringent regulatory framework known as premarket approval.
AdvaMed plans to work with the FDA on 510(k), Mazzo said. It’s established a working group of device executives that wants to see the regulatory agency implement a review plan to improve timeliness and consistency. Elements include things such as advanced training for FDA reviewers, more use of external scientific experts and streamlining regulation for the lower-risk devices.
“I think the agency was surprised by the report,” said David Gollaher, chief executive of La Jolla-based industry group California Healthcare Institute.
The group includes Michael Mussallem, chief executive of Edwards Lifesciences Corp. in Irvine, which makes replacement heart valves; David Pyott, chief executive of Irvine-based Allergan Inc., which makes various devices along with Botox and other drugs; and Michael Drake, chancellor of the University of California, Irvine.
Earlier this summer, California Healthcare Institute added its voice to the chorus of executives and industry representatives who called for improving the 510(k) program with an eye on achieving consistency and predictability.
“It has worked very well—doesn’t mean it’s worked perfectly, but it’s worked well,” Gollaher said.
Scrapping 510(k) would mean passing federal legislation to create a new regulatory program. That would be “unimaginably complicated, particularly in the current political environment. We sort of take our page from looking at the real world. … nobody wants unsafe products.”
The Medical Device Manufacturers Association, a Washington, D.C., group, “completely (disagrees) that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it,” Mark Leahey, its chief executive, said.
Leahey said it’s “also important to remember that studies prove the 510(k) process has a strong track record on patient safety.”
The willingness to work with the FDA is likely a matter of device makers’ desire to avoid a potentially volatile political mix.
“If you have a complete overhaul, Congress would get involved—and that’s not good for anybody,” said Evan Ng, a partner with Dorsey & Whitney LLP, which represents emerging device makers.
If there is extensive lawmaker involvement in medical device regulation, it might carry a big risk for the industry “because it may mean more stringent requirements for all devices. It’s quite conceivable that Congress will shape policy based on a handful of horror stories rather than just generally promoting innovative devices,” Ng said.
In the meantime, the FDA has also been taking its own internal look at the 510(k) program.
An agency report last year contained more than 70 proposed changes to the process. Some of those included creating a subset of moderately risky medical devices, such as infusion pumps used to deliver drugs and fluids to patients. Those devices would require more safety data included in their submissions.
Another suggestion was streamlining regulatory applications for devices that don’t resemble earlier ones and won’t require human clinical trials because of low safety risks.
Creating a database to offer the public access to FDA review decisions and device labeling also came up in the report.
One suggestion that’s been acted on was creating a science council made up of FDA reviewers and managers to assure quality and consistency over tougher device science questions.
“Our intent here is to truly strengthen the program and to strike the right balance,” Shuren said last year.
Regulators ordered a review of 510(k) about two years ago after Congress members and consumer advocates alleged that the FDA wasn’t adequately protecting patients. Existing regulatory processes hadn’t kept up with technology, which has disrupted the pace of approvals, according to critics in the industry.
The 510(k) program has existed since 1976.
Besides 510(k), the agency also has what’s called “premarket” approval to look at more medically complex, higher-risk devices, including those that are implanted in the body.
Defibrillation machines that restore heartbeats are an example of a medical device that’s reviewed for premarket approval.
“Those are subject to more intense scrutiny, with clinical data and clinical trials that have to be done,” Gollaher said.
Although premarket approvals weren’t addressed by the institute’s report, “our point is we need to see improvement (both) at the PMA level and the 510(k) level,” Mazzo said.