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CDRH seeks input on preliminary 510(k) program and utilization of science reports
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To address concerns about the FDA’s 510(k) reform process, the Center for Devices and Radiological Health (CDRH) held a 2-hour Webinar on August 31, allowing FDA officials to answer questions that medical device companies and others have about the Center’s preliminary assessments of the FDA’s 510(k) program and how science should be used in the decision-making to clear medical devices.
The Webinar took place nearly a month after the August 4 release of the FDA’s two documents, which provided comprehensive evaluations of the 510(k) program for clearing medical devices, entitled “Center for Devices and Radiological Health Preliminary Internal Evaluations.”
The reports were compiled by two internal committees formed in Fall 2009, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.
An Institute of Medicine committee is conducting a separate evaluation of whether the current 510(k) premarket notification protocol promotes safety and public health.
Improvement needed
During the 510(k) revamping process, the CDRH conducted “significant outreach” via town meetings and public dockets to obtain needed input on the documents from stakeholders, Jeffrey Shuren, MD, director of the CDRH, said. The Webinar provided another forum to address questions raised during the 60-day review period for the documents, which ends October 4.
“There’s widespread recognition that there’s significant room for improvement in the way we operate,” Shuren said during the Webinar.
“These reports represent a blueprint for smarter medical device oversight with the tools CDRH needs to drive innovation and help bring the best technologies to patients while continuing to ensure the safety and effectiveness of medical devices,” he said.
In addition to Shuren, those fielding questions from the virtual audience were Alberto Gutierrez, MD, Office of InVitro Diagnostics CDRH; Christy Foreman, Office of Device Evaluation CDRH; and Dr. Jonathan Sackner-Bernstein, Associate Center Director, Post Market Operations, CDRH. The event’s format involved online participants anonymously e-mailing questions about the Draft 510(k) and Use of Science in Regulatory Decision Making reports to the CDRH officials, who answered them aloud.
Both reports are available at the FDA’s website.
New device classes
Some of the questions centered on concern over whether the review of current or soon-to-be submitted 510(k) applications would be impacted during the 510(k) revamping process. Shuren said that the Center’s work to finalize the two reports, which are expected to be complete later this year, with some recommendations possibly being phased in, would not affect the timeline for review of 510(k) submissions in process. He also noted the existence of these preliminary reports should not keep companies from submitting their new products for 510(k) clearance.
Since the 510(k) Working Group has proposed changes to the premarket notification program that include introducing subsets of class II devices of class IIa and class IIb, this spawned questions about the type and level of evidence needed for them. For new class IIb devices, clinical or manufacturing information or potentially additional evaluation in the post-market setting may be required to support substantial equivalence claims, according to the 510(k) Working Group report executive summary.
When asked whether stakeholders may provide input to the Center on the criteria for devices that are appropriate for class IIa vs. IIb, Shuren said, “The public will have input. What we plan to do is issue draft guidance and get public comment on that before we would go out with final criteria.”
New de novo approach
CDRH’s Foreman discussed the level of clinical data for 510(k)s compared to premarket approvals. “Part of what we would like to achieve with this report and clarity applied to the regulatory process is identifying up front which devices we think would need clinical data, but by saying a 510(k) needs clinical data, that doesn’t necessarily mean that it needs a double-blind, randomized control study of 1,000 patients. We just need some level of clinical evidence to establish the equivalence of that device,” she said.
Among the many other questions were inquiries about the proposed recommendations related to rescinding a 510(k) clearance and off-label use considerations.
Shuren said the Center’s assessment requests expediting the handling of de novo devices. Currently they require a non-substantially equivalent determination via the 510(k) process before being considered for clearance through the de novo pathway. “The Center is recommending that we take steps to streamline this process so it truly is a viable path forward for lower risk novel devices,” he said.
The science report included plans to enlist the help of more outside experts as resources in the device evaluation process, among other recommendations.
Reference:http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm
The 510(k) process is an outgrowth of the 1976 Amendments to the Food, Drug and Cosmetic Act (FDCA) which brought medical devices under federal regulation. Its intent is to provide the American public with safe and effective products for the treatment of physical impairments through a defined approval pathway in a reasonable timeframe.
The 510(k) process relies on the identification of a clinically used predicate for which a contemporary product claims simile. Changes to the process should assure that the claimed predicate enjoys clinical success as defined in the peer-reviewed literature. Clinical information where the contemporary product has been employed outside of the United States can assist the process as well as the increasing realization that technical proficiency plays a major role in assuring function and product longevity in a patient. The call for post-approval surgeon training and follow-up would not seem an undue burden as part of a further subcategory (IIb). Additionally, the intent of the FDA’s MedWatch adverse event reporting program to serve as a clinical tripwire when product failure occurs can only be enhanced if the American Joint Replacement Registry (AJRR) is involved.
Upending the 510(k) process by requiring extended clinical evaluations before approval would end orthopaedic product innovation in the United States as small, technology driven orthopaedic companies could ill afford to innovate while the larger ones would be reluctant to risk the financial resources required in a rapidly changing product environment. This would be a prescription for surrendering the field, resulting in follow-on product mediocrity. This is not in the best interest of continuing to foster cost-effective improvements in healthcare for the American public.
— A. Seth Greenwald, D.Phil.(Oxon)
Director
Orthopaedic Research Laboratories