FDA insisted Aug. 31 that its planned reforms to the 510(k) program will not dramatically raise the bar for clinical data submissions.
510(k) Reform Does Not Mean Major Increase In Clinical Data Demands - FDA
Article preview from "The Gray Sheet" - September 6, 2010
"It is not our intent to turn the world upside down for device manufacturers," Christy Foreman, acting director of FDA's Office of Device Evaluation, said during a Web-based seminar for industry.
The agency organized the session to provide more information to companies following the recent release of internal reports on proposed reforms to the 510(k) program and on ways to incorporate new regulatory science into FDA reviews (1 'The Gray Sheet' Aug. 9, 2010).
Foreman and other officials fielded questions about how potential changes to the 510(k) program could impact the quality and quantity of clinical data required in a 510(k), among other issues.
"By saying a 510(k) needs clinical data, that doesn't necessarily mean it needs a double-blind, randomized controlled clinical study of 1,000 patients," Foreman said. "We just need some level of clinical evidence to establish the equivalence of that device."
The "quality" of the clinical data required in a 510(k) will depend on the device technology, CDRH Director Jeffrey Shuren added. FDA will try to be clearer about what data is required for what types of devices, he said.
"Clinical data is a fairly broad term," he said, and, beyond randomized trials, could include human factors data or case-controlled trials, as well as data from studies conducted outside the United States.
Industry Can Weigh In On Class II Division
Among the items in the 510(k) reform report, FDA proposes splitting up the moderate-risk, Class II category of devices into two subsets to make it clearer what types of products will generally require clinical data to be included in a 510(k) submission.
Industry stakeholders questioned during the recent session what criteria FDA would use to split up the category, and whether there would be a chance to weigh in on that process.
"The public will have input," Shuren affirmed. "We plan to issue draft guidance and get public comment on that before we would go out with final criteria."
As to the number of devices that would fall into Class IIb, the proposed designation for products that would "typically" require clinical information, FDA hasn't gone through the process of sorting that out.
"I would say it's probably not on the order of one or two devices and it's probably not on the order of hundreds of devices," Foreman said. "It's somewhere in between."
The Class IIb guidance will also explain what types of devices might be subject to further requirements, such as pre-510(k) clearance facility inspections.
But "we're not anticipating that pre-clearance inspections would be many in number," Shuren added.
More Detail On De Novo Reforms
The center staffers also went into detail on potential reforms to FDA's 'de novo' approval process, which provides a market pathway (other than a PMA) for products deemed to be relatively lower risk but without an appropriate predicate device to pass 510(k) muster.
Specifically, FDA is considering removing the requirement that companies first go through the full 510(k) review process, get rejected, and then submit a de novo request, Shuren said.
Instead, FDA could use its pre-investigational device exemption process to determine what regulatory pathway a device should take, the speakers suggested.
In addition, "we're going to be posting our review memos on our website so you can see the basis that went into our decision-making for the de novo process," Foreman said. "That will allow any manufacturer who wants to market a device that would be equivalent to that de novo approved device the ability to see the agency's thought process."
Written comments on the 510(k) and new science reports are due Oct. 4. FDA would like specific comments on which recommendations should be phased in over time, versus implemented immediately, Shuren noted. "Our hope is to put out those recommendations that we plan to adopt later this year," he said.
- Jessica Bylander
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