CIMIT: August 2010 Regulatory Affairs Newsletter

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August 2010 Regulatory Affairs News

Additional information on these topics is available at www.thegraysheet.com (paid subscription service).

Weekly Device Summaries for August 9 - 13, 2010

FDA Publishes Report on 510(k) Reform. FDA has released findings from an internal study group tasked with evaluating the 510(k) premarket notification program for medical devices. The long-awaited report proposes various reforms to the program, including a new classification category for certain devices. Additionally, the report suggests that FDA require postmarketing surveillance for higher-risk devices cleared for marketing through the 510(k) program. The working group recommends that FDA define the circumstances under which the agency could rescind or modify a 510(k) decision and addresses the use of predicate devices to support a 510(k) notice. The agency will accept comments on the proposals until October 4, 2010.

Report Examines Use of Science in FDA Decisions. FDA has released a report that seeks to improve the use of science in the agency’s regulatory decision-making. The report makes 17 recommendations that would enable FDA to make better use of new science, including a four-step process for responding internally to new scientific data. Of concern to the device industry, the report also suggests that legal provisions seeking to limit the regulatory burden on industry have been interpreted too broadly in the past. As a result, the report authors recommend that FDA limit the scope of these provisions, which could lead FDA to request more data prior to approving devices for marketing.

Advisory Panel Process May Be Tweaked Further. FDA’s device center has indicated that more modifications may be made to the advisory panel process, which is used to obtain insight from clinicians on devices under premarket review by the agency. In May, FDA changed the voting process for advisory panels, such that members would no longer take a public, up-or-down vote on whether a device should be granted marketing approval. Instead, panelists now vote electronically and anonymously on whether there is reasonable assurance of a device’s safety and effectiveness. After the first two meetings using the new procedures, however, the device center has said it is still assessing the optimal panel process.

Weekly Device Summaries for August 2 - 6, 2010

FDA, FCC to Collaborate on Wireless Devices. The FDA and Federal Communications Commission (“FCC”) have agreed to work together to regulate broadband or wireless products that incorporate health-related technology. At a meeting on July 26, 2010, FDA and FCC released a memorandum of understanding, in which the two agencies agree to share information and expertise in regulating the devices. FDA and FCC also issued a joint statement of principles, in which the agencies emphasize the government’s support of innovative wireless medical products. As part of the joint initiative, FDA will soon issue guidance on wireless medical devices.

IOM to Begin Private Deliberations on 510(k) Program. The Institute of Medicine (“IOM”), which has been tasked with reviewing FDA’s premarket clearance program for medical devices, has moved into a closed-door deliberations phase. After months of holding public meetings regarding the 510(k) program, the IOM now will meet privately to discuss its final recommendations and draft a report of its findings. The IOM review was prompted by critics of the 510(k) program, who contend that it allows medical devices to be cleared for marketing too easily. The final IOM report is expected in May 2011.

Industry Comments on New Infusion Pump Requirements. Infusion pumps should be regulated based on risk, according to device industry groups addressing recent FDA proposals. As part of its new infusion pump initiative, FDA recently issued draft guidance proposing new premarket requirements for the pumps. In comments on the guidance, industry trade groups noted that the wide variety of available infusion pumps cautions against a one-size-fits-all approach. Rather, device trade group AdvaMed suggested FDA utilize a two-tiered approach, with more stringent requirements for high-risk devices than low-risk pumps.

Additional information on these topics is available at www.thegraysheet.com (paid subscription service).