Recent events—including media attention on what some have called inconsistent application of the process—have triggered FDA to take a look at the 510(k) process. And although a review of the process is good, care must be taken to avoid overdoing it. The process does work as it was intended, and any major overhaul would risk hurting innovation and delay patients’ access to improved devices.
The original intent of the program was to provide substantially equivalent information to the physician for diagnosis and for
substantially equivalent device performance. “If the device or diagnostic technology does this, or does it somewhat better, and the sponsoring company demonstrates that without FDA believing that there are new and significant questions of safety or effectiveness, the American public is best served by accelerating new products to the market,” says Jim Hitchen, CEO of SpectraScience (San Diego), which develops diagnostics for cancer detection.
substantially equivalent device performance. “If the device or diagnostic technology does this, or does it somewhat better, and the sponsoring company demonstrates that without FDA believing that there are new and significant questions of safety or effectiveness, the American public is best served by accelerating new products to the market,” says Jim Hitchen, CEO of SpectraScience (San Diego), which develops diagnostics for cancer detection.Hitchen does say that industry should work with FDA to address any parts of the 510(k) process that aren’t working the way they were intended to work. For example, he says that there needs to be improvements to address the inconsistencies between branches and between reviewers.
AdvaMed has issued a statement in support of FDA’s current risk-based approach to medical device regulation, noting that “the 510(k) process gives robust protections to American patients and promotes medical innovation by providing FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk products.”
The group also says that while the basic structure of the 510(k) process works very well and has evolved over time to better meet the needs of American patients, it recognizes that there is no process that cannot be improved.
Hitchen says that the main problem he sees with the process is that submission requirements are a moving target—not only within the branches but also between reviewers and between the branches. Rather than a problem with the process, he suggests that many of the latest problems are the result of “a management problem that has been endemic at FDA since the Medical Device Amendments. It seems that most of CDRH is managed bottom up. Recent evidence of this was the exit of Dan Schultz when he made executive decisions his reviewers didn’t like.”
Technological advances should not be the reason for change to the process. “If you look at the historical advances from radio immunoassays to enzyme immunoassays, for instance, you see diagnosis that provides the same or better or faster sensitivity and specificity.” But, he says, “they are truly substantially equivalent in that they provide the same diagnostic information to the physician.”
One important aspect of the process may very well be getting lost in mainstream media coverage of FDA. “It is important for patients to know that devices cleared via the 510(k) process undergo thorough FDA review,” explains AdvaMed. “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.”
Increasing the bureaucracy would only make it harder to cure some of these patients more quickly. “Diagnosing patients earlier saves lives and prolongs lives. So getting new life-saving products to market more quickly is very important,” Hitchen says.
AdvaMed says that it looks forward to the Institute of Medicine conducting a thorough and objective analysis of the 510(k) process, believing that the analysis “will underscore the strengths of FDA’s current regulatory approach and dispel many of the misperceptions about the process.”
So there may be some changes that need to be made. But the 510(k) process has a proven track record of protecting the public while getting new products to market. “If this process is overhauled to take more time, patients are the losers,” says Hitchen.
Sherrie Conroy [5] for the Editors