Medical Device Daily Washington Editor

Yesterday's meeting with managers at the Center for Devices and Radiological Health at FDA to address the much-maligned 510(k) program painted a picture that had to be discouraging to industry for a couple of reasons. One is that FDA staff indicated that the center's reviewers are swamped with the several types of 510(k) applications and the other is that the "predicate tree" is described in data files at FDA that are often either incomplete or have been truncated, leaving a dead end trail for those inside and outside the agency who are attempting to flesh out the current state of affairs for a device type.

While several of those who presented on behalf of industry addressed what they saw as inconsistencies in standards at FDA, others complained that at least some FDA reviewers are loathe to answer phone calls and e-mails. Industry also argued for a level playing field regarding the agency's treatment of substantially equivalent device applications, but the agency's personnel gave no hint that they see this is an overarching consideration.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health, opened the meeting with the remark, "I am pleased that today's meeting . . . has attracted so much attention," adding that the docket for comment will remain open until March 19. He reminded the audience that the 510(k) program was "first created by Congress over 30 years ago," but that "in recent years, concerns have been raised both inside and outside FDA" as to whether the program "achieves its goals" of simultaneously encouraging innovation and protecting public health.

Shuren also noted that two assessments of the program are underway, including a review by the Institute of Medicine, which will hold a public meeting on March 1. He also noted that the internal review, led by Donna-Bea Tillman, PhD, director of the Office of Device Evaluation, will be summarized in a report due by the end of May. Any changes adopted as a result of that report will be in force by September.

"We still have a way to go before the center makes any final decision regarding the program," Shuren promised.

Tillman reminded attendees that FDA's "regulatory framework is based on risk," and that the congressional record for the Medical Device Amendments of 1976 suggests that the concept of substantial equivalence was "not intended to be so narrow as to refer only to devices that are identical" to the predicate, but should allow some innovation.

Tillman made some effort to debunk claims that the 510(k) process is a fast-track approach, stating that the fact that the presence of a predicate "doesn't mean FDA just rubber-stamps that 510(k)." However, she acknowledged a tension when a new indication seems to imply a new intended use. "Trying to walk that line is an area of challenge," she said.

Tillman said that evolving medical technology "continues to fundamentally transform healthcare and delivery," but that this "constantly innovating technology is going to challenge our regulatory systems." She added that the agency "need[s] to find a way to align" regulations with "the fundamental changes in device technology that are coming."

"I think science is going to continue to advance rapidly," Tillman observed, suggesting to device makers that both industry and the agency "need to think about how our regulatory process needs to evolve." However, she also warned that such regulatory evolution is "not going to be a one-shot deal" because "as technology continues to fundamentally and rapidly advance," the regulatory scheme will have to morph as well.

Christy Foreman, the deputy director for engineering and science review at CDRH, opened her remarks by stating that there is a direct link between the latest device iteration to the ancestral predicate form. "One thing we need to keep in mind" is that "once we say it's substantially equivalent, it all traces back to that original device," she said.

Foreman said that device makers "often lack sufficient information to select an appropriate predicate," in part because the agency often redacts materials that could be useful. FDA's documents "often lack critical details," she said, adding that a 510(k) statement "relies on a manufacturer offering a competitor" critical information, hence the redaction.

Old predicates are also a problem, Foreman said, in that "it can be difficult to compare a device that is microprocessor-controlled to a predicate device" that lacks such technology. She also voiced the view that FDA "must deal with a lowest common denominator" in terms of predicate selection, alleging that manufacturers sometimes choose a sub-par device as a predicate. "How can FDA best address this issue?" she asked.

Foreman made the case that manufacturers "may decide not to submit a 510(k)" for incremental modifications for marketing advantage, offering the hypothetical case of a modified user interface for a dialyzer. "The firm knows there is a growing demand" for devices used in the home, and may make changes, for example, to the user interface without any intent to provide a device that is truly more effective. A practice of selecting a predicate that is "not worse than" its predecessor, Foreman continued, allows performance for that device category to deteriorate over time. "The newly cleared device leads to the next predicate," hence a chain of lessening performance numbers, she alleged.

Another dilemma is encountered when a string of unapproved changes puts FDA in a predicament "so when a new 510(k) is filed," FDA has to play catch-up on "those 32 changes" made in the meantime, Foreman said.

Heather Rosecrans, director of the 510(k) staff at the Office of Device Evaluation, checked off some of the difficulties encountered by her staff. "Our first challenge related to post-market" considerations is that FDA's authority to mandate surveillance "is limited," she said.

Rosecrans pointed out that "unlike PMAs, we do not have explicit authority" to require post-market studies as a condition of approval, although FDA can issue a 522 order after the fact of clearance. The agency recently issued a 522 post-market evaluation order for dynamic spinal stabilization systems (Medical Device Daily, Nov. 17, 2009), although those studies are still in development.

Rosecrans also noted that the agency has limited authority to rescind a clearance, but added that while keeping the playing field level "is an essential part of the 510(k) process," she said "it is challenging" in light of evolving evidence.

Manufacturers sometimes do not help their cause, Rosecrans hinted, noting that "we often find" that firms "make significant changes to labels and go to market" after agreeing to a label's content. Some of these "would require a new 510(k)," she said. Minor changes to a device that require no formal filing must bear the same label, but "if we had to review the labeling" for all such instances, "it would be a big workload."

Rosecrans also remarked that there is no reporting requirement for sale or transfer of a 510(k). "You can imagine how difficult it is for FDA to investigate" adverse events when the ownership of a 510(k) number is unknown, she observed (The second part of our coverage of this meeting will appear in Monday's edition of Medical Device Daily).

Mark McCarty, 703-268-5690
mark.mccarty@ahcmedia.com