Medical Device Daily Washington Editor
The normal course of affairs at FDA meetings – advisory meetings and other kinds – is that government employees do not speak as private citizens and that center and division chiefs do not represent FDA at those meetings. For the second time in 16 months, this pattern was broken as Robert Smith, MD, a reviewer of radiological products at the Center for Devices and Radiological Health, took to the podium to present his views as a private citizen on the 510(k) program.
The previous example was when former CDRH director Dan Schultz, MD, and Larry Kessler, ScD, who at the time was director of the Office of Scientific and Engineering Labs at CDRH, appeared at the advisory committee hearing for the now-notorious Menaflex 510(k) application (Medical Device Daily, Nov. 18, 2008).
The predicate device controversy seems assured of staying power, given the impending March 1 meeting of the Institute of Medicine on the 510(k) program, but the U.S. Senate is back in the mix, too, as evidenced by a Feb. 16 letter by Iowa Republican Chuck Grassley. Addressed to FDA commissioner Margaret Hamburg, MD, Grassley's letter requests further information on the 510(k) program in relation to the controversy over the Myxo ETLogix 5100 annuloplasty ring, made by Edwards Lifesciences (Irvine, California)(MDD, Dec. 8, 2008), but his interest is in the status of a revised guidance over when a 510(k) is and is not required for device modifications.
Smith presented on the agency's behalf during two controversial meetings of the radiological devices advisory committee during which he argued that clinical testing is essential for clearance of full-field digital mammography systems (MDD, Nov. 19, 2009). His message at those meetings was rebutted by industry as well as a number of academic physicians, including the lead investigator for the definitive DMIST (Digital Mammographic Imaging Screening Trial) study, Etta Pisano, MD, of the University of North Carolina School of Medicine (Chapel Hill, North Carolina).
Smith led his discussion last Thursday with a disclaimer, saying, "I'm not speaking today in an official capacity for CDRH or FDA, and my comments today do not represent the views" of the center or the agency. He then proceeded to offer a review of regulations, primarily 21 CFR chapter 860, the portion of the code dealing with the types of evidence required to obtain clearance for a device based on a predicate.
"The standard of scientific and clinical evidence is the same for PMAs and 510(k)s," Smith argued, adding that "substantial equivalence is a safety and effectiveness determination that must be made using only valid scientific evidence" made only by "qualified experts." Smith added that "FDA can do outstanding science and clinical work only if FDA has outstanding scientists and clinicians," all points he reiterated later in his five-minute discussion.
Smith remarked, "There are two distinct paths to 510(k) clearance," one of which is to make a device that "has the same intended use as the predicate and the same technological characteristics." The second available path, Smith informed the other FDAers, is a device with the same intended uses but different characteristics. The data requirements here include "clinical data, if deemed necessary by the commissioner, which demonstrates that the device is as safe and as effective as the legally marketed predicate." This assumes that the newer item does not raise new questions about safety and effectiveness, Smith said, adding the proviso that "it's important to keep in mind that the safety and effectiveness of the predicate device may change over time as more information becomes available."
Among Smith's closing remarks were that "strengthening the [510(k)] program should include ensuring that the laws, rules and regulations are strictly followed, ensuring that safety and effectiveness determinations are made by scientific clinical experts only." He further urged "protection of scientific and clinical experts with a zero tolerance policy regarding retaliation and harassment."
The last remark seemed to echo comments in letters addressed to congressional leaders and the White House, with the April 2, 2009, letter to President Obama alleging "misdeeds of FDA officials" who were purported to have "abused their power" and "engaged in illegal retaliation against those who speak out."
Also appearing at the podium was Mark Leahey, President/CEO of the Medical Device Manufacturers Association (MDMA; Washington), who described the 510(k) program as "one of the great successes at FDA," and one which has had "a positive impact on patient care."
Leahey said that the analysis of the program by the Government Accountability Office "came up with some reasonable recommendations" on the disposition of legacy devices that were in play when the Medical Device Amendments of 1976 was passed, but that GAO made no argument "that the program is dysfunctional." He made the case that many of the complaints lodged against the program for undue ease are offered by "those who have neither submitted a 510(k) nor reviewed one in their entire career," and argued further that consumer advocates can "hide behind the generalities, but if you have a loved one in need of" a lifesaving device, the picture might seem to shift.
"I hope we don't conclude strengthening" means slowing approval times or the pace of innovation, Leahey said. As for innovation, "we hear a lot about protecting patients," he said, but "the system in the past three years or so has become less predictable," including demands imposed mid-stream for longer follow-up of patients or larger trials for PMA applications. Such situations are a hazard for small firms "in this environment. Maybe three or four years ago you could raise the money" to comply with the additional demands but the financial market is not so amenable now, he said.
"As we move forward, we're not suggesting the entire system is perfect," Leahey said, but added that "for the overwhelming majority of 510(k)s, there's not an issue." However, he asserted that a substantially more difficult terrain for 510(k) devices, which are often funded by venture capitalists, will have an impact on "the innovation ecosystem."
In a Feb. 18 statement, Janet Trunzo, executive VP for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed; Washington) said the 510(k) process "provides strong protections to American patients and promotes medical innovation." She also argued, "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," although she said that the association's members "recognize that there is no process that cannot be improved."
Trunzo also charged that the process "has erroneously been called a 'fast track' process by too many in the media." She closed by stating that industry "looks forward to the results of FDA's internal 510(k) review and any recommendations it might adopt to improve transparency and predictability in the review process."
Mark McCarty, 703-268-5690