The Food & Drug Administration convened a day-long public hearing on its 510(k) clearance program for medical devices in Washington, D.C., Feb. 18, drawing comments from a variety of stakeholders.
The program, by which the vast majority of medical devices are approved by the watchdog agency, is often called a "fast-track" program because it relies on previous approvals of similar or "predicate" devices. Supporters of the process say that’s a misnomer; detractors say the system isn’t as rigorous or robust as it should be.
At the open forum Feb. 18 in Washington, Diana Zuckerman, president of the National Research Center for Women & Families, said the 510(k) process has "major problems" requiring "major improvements."
Zuckerman, who said her roots are deep in the medical device industry (her father "worked for a major medical device company and my family has substantial stock in that company," she said), cited a soon-to-be-released study by her group showing that a significant number of Class I recalls — products the FDA believes could cause serious injury or death — are for 510(k) devices.
"The data are clear looking at recalls. The vast majority are 510(k) products and some that are supposed to be exempt [from the 510(k) process]," Zuckerman said. "We know these products are not supposed to be high-risk, so why are they being recalled if they’re 510(k) products?"
Kelly Slone, director of federal life science policy for the National Venture Capital Assn., said changes to the system could endanger innovation driven by small start-ups.
"These young companies, as years go on, get more fragile and harder to raise money and invest even though they have great ideas," Slone said. "A critical part of the innovation ecosystem is at risk. VCs, when looking at innovative technologies, have to make a judgment on risk assessment to invest in novel technologies. … Historically, we believe 510(k) is workable, but over three years there’s been a disturbing trend on impeding innovation. Why is this happening? We believe it’s because a burdensome regulatory environment has greatly reduced innovation. We believe there needs to be a process to review novel technologies."
At a round-table discussion following the open forum, Craig Coombs of Coombs Medical Device Consulting said the 510(k) process, which was created in 1976, has become outdated in the intervening years.
"We can clean her up and give her dance lessons, but it’s still the same girl," Coombs said. "Very few of us will have the same business process as we had in 1976."
The 510(k) system is already under intense scrutiny from within and without the FDA, which commissioned the Institutes of Medicine for a $1.3 million review and is conducting its own, internal investigation.
Early results from that examination, detailed in a memo leaked to the Wall Street Journal, show that the agency is considering a variety of options. Of special concern to the FDA is the so-called "special 510(k)," which allows manufacturers to receive approval within 30 days for a device that’s identical to a predicate product save for a single modification. Agency officials discussed scrapping the special 510(k) program altogether, according to the newspaper, or keeping it but making its rules more stringent. About a quarter of all 510(k) applications are made under the special 510(k) program, according to the memo. One problem with the system is the difficulty the agency has in verifying the truth of claims made by applicants, according to the memo, and at least one such approval was rescinded "based on false information," the Journal reported.
The agency is also concerned about the use of contractors hired by device makers to review products before a 510(k) application, according to the newspaper.
"If the third party signs off on the device, the FDA may approve it without much further scrutiny," the newspaper reported. "The memo notes the ‘Real value to industry may be that this is perceived as a way to "sneak things in."’"
Third-party reviewers "often just repeat what is in the submission” without further scrutiny, according to the leaked memo, which could lead to the FDA limiting the devices it allows to be reviewed by outside contractors. About 300 applications were reviewed by third parties during fiscal 2008, up nearly 63 percent since 2003.
The FDA isn’t the only one with concerns about the process. Sen. Charles Grassley (R-Iowa) sent a letter to the agency Feb. 16 asking for an update on its plans to issue new 510(k) guidelines. Grassley’s interest was piqued last year when he heard about a device made by Edwards Lifesciences (NYSE:EW), the Myxo dETlogix annuloplasty ring.
"Over a year ago, I wrote to the FDA regarding serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA. The FDA concluded that the company had made the wrong decision when it marketed the product without first seeking clearance from the Agency," Grassley wrote. "That device … has since been cleared by the FDA, but as I stated in my letter to the FDA last April, the fact remains that for more than two years, patients at Northwestern Memorial
Hospital were being implanted with the device before a 510(k) was submitted to the Agency."
Grassley wants a response from the FDA by March 2, answering questions about how and when manufacturers are required to update their device listings with the agency, how patients and doctors can "obtain information about the status of a device other than from the manufacturer itself" and whether manufacturers must update their listings if device names are changed without modifications to the product, or if modifications are made that don’t require a new 510(k) application.
Tim Mohn, industry principal for compliance technology firm Sparta Systems, told MassDevice that the scrutiny of the 510(k) process can mean only one thing in the end.
"The only possible outcome is things will get more stringent. The variable within the stringency will be whether the regulations actually change, or will the agency just take a more conservative approach to enforcement?" Mohn said. "Approvals are taking longer across the board, and the underlying thing is that American consumers are looking for independence from the agency and a sound, scientific, medical rationale in the approval process."
The Advanced Medical Technology Assn. (AdvaMed), the medical device industry’s lobbying arm in Washington, said in a prepared statement that the "already robust" 510(k) process "provides strong protections to American patients and promotes medical innovation."
"It gives FDA the flexibility it needs to ensure the safety and effectiveness of incremental changes made to low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices," according to the statement. “It is important for patients to know that devices cleared via the 510(k) process undergo thorough FDA review. It has erroneously been called a ‘fast track’ process by too many in the media. That is an inaccurate characterization. The length of review is determined by FDA and based on potential impact to public health and on technological complexity. It is also important to note that FDA has total authority under the 510(k) process to require whatever evidence is necessary to assure a product’s safety and effectiveness, including clinical data when it deems this data to be necessary to assess the risks and benefits of a product."