Full article reprinted from "The Gray Sheet"- February 22, 2010
FDA is considering changing how predicate devices are selected for 510(k) submissions and beefing up its post-market authorities for 510(k)-cleared products, agency reps suggested at a Feb. 18 public meeting. Read more...
Full article reprinted from "The Gray Sheet"- February 22, 2010
FDA Hints At Possible 510(k) Tweaks At Public Meeting
FDA is considering changing how predicate devices are selected for 510(k) submissions and beefing up its post-market authorities for 510(k)-cleared products, agency reps suggested at a Feb. 18 public meeting.
FDA convened the workshop as part of its broader efforts to reevaluate and potentially modify its longstanding 510(k) review program. The meeting took place in Gaithersburg, Md.
Concerns have been raised in recent years - inside and outside the agency - over whether the program achieves its intended goals of bringing safe, effective and also innovative devices to market, FDA acknowledges.
The device industry, meanwhile, is worried that FDA is weighing a substantial overhaul to the program through which over 90% of medical devices enter the market.
Companies at the meeting urged FDA to at most change how it implements the pre-market submissions program, rather than revamp the program itself.
The purpose of the workshop was not to announce changes in policy, but to seek input from interested stakeholders, FDA stressed.
"We are in the evaluation phase," device center director Jeffrey Shuren told reporters after the meeting.
"Let's look under the hood and see if there are any problems" and then determine what actions to take, he said.
Predicate Device Questions Highlighted
Device center officials at the workshop presented key issues related to 510(k) predicates; new technology and science; strategies for managing high volumes of 510(k) submissions; and post-market surveillance.
The topics that FDA chose to present signal places where, at minimum, policy tweaks are being considered. "Those are certainly areas where we've seen challenges," Shuren said after the meeting.
Christy Foreman, a deputy director in CDRH's Office of Device Evaluation, highlighted a number of questions about the use of predicate devices, which form the basis of 510(k) substantial equivalence claims.
Manufacturers sometimes have trouble selecting an appropriate predicate device with which to compare their new device, Foreman noted.
Firms sometimes choose the "lowest common denominator" device as a comparator, or they may reference multiple predicates for a single new submission, she said.
FDA is toying with a few ideas for improving use of predicates, such as publicly releasing more data about cleared devices or restricting the use of technically outdated or clinically irrelevant predicates.
"How can the program effectively and efficiently evolve if devices from 1976 set the bar for comparison?" Foreman said. "How can the agency deal with a predicate device that has sub par performance compared to other devices in the class?"
FDA says it has, on occasion, required firms to select a different predicate than the companies originally proposed.
510(k) Modification Issues Resurface
FDA also voiced questions about how to deal with incremental changes to 510(k) devices. Small modifications may not need to be reported to FDA, but the agency is worried about whether a slew of small changes can add up to new questions about safety and effectiveness, Foreman noted.
Republican Senator Chuck Grassley, for one, is calling for more active FDA oversight of these minor modifications (see sidebar: 1 'Grassley Wants Update On 510(k) Modifications Guidance').
Bundled 510(k) submissions and third-party 510(k) reviews may be another cause for concern, ODE Deputy Director Barbara Zimmerman stated in her workshop presentation.
About 8% of 510(k) devices are reviewed by FDA-accredited third parties, but the quality of those reviews could be improved, she acknowledged.
Though the third-party program is meant to help FDA extend its limited resources, some agency staffers are questioning the increasing use of private companies to conduct reviews, according to a Feb. 17 story in The Wall Street Journal that cited a Dec. 22 FDA memo.
The internal memo notes that firms may see the program "as a way to 'sneak things in,'" according to the Wall Street Journal report.
Agency Wants More Post-market Authority
Meanwhile, Heather Rosecrans, head of CDRH's 510(k) policy staff, raised concerns about FDA's limited post-market authorities when it comes to 510(k)-cleared devices.
Unlike with PMAs, for instance, FDA lacks the authority to require post-market studies as a "condition of clearance," she said.
In addition, FDA's limited authority to rescind 510(k) clearances makes it "difficult for FDA to address problematic predicates," Rosecrans said.
The agency 2 proposed a 510(k) rescission regulation in 2001, but never finalized it.
FDA could also use the authority to require 510(k) holders to report the purchase, sale or transfer of ownership of the 510(k) to the agency, she said.
Currently, firms can report this information voluntarily to FDA, but are not required to do so. And FDA cannot confirm that the voluntary information reports are accurate.
Device firms at the meeting agreed that post-market mechanisms could help FDA address safety and efficacy questions that cannot be answered prior to product clearance.
FDA Will Not Wait For Institute Of Medicine
The meeting was only one of many steps FDA is taking in its reassessment of 510(k)s.
The agency will also get input on potential 510(k) reforms from a pending report due in 2011 from the Institute of Medicine, recommendations from its own internal working group and public comments.
IOM is holding its first public meeting on the 510(k) program on March 1 in Washington, D.C.
But FDA will not wait for the IOM results before making changes to the program, Shuren said. FDA's internal working group will likely propose short-term changes and may even determine that some statutory changes are needed, he said.
Any actions that FDA takes now can also be factored into IOM's report, the center director pointed out.
The working group is set to submit a report to Shuren by the end of May, and soon after FDA will release the report for public comment, Shuren said.
FDA will then decide which recommendations to adopt and begin implementing them by the end of September.
- Jessica Bylander
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