CIMIT: February 2010 Regulatory Affairs Newsletter

February 2010 Regulatory Affairs NewsPrint this page

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Weekly Device Summaries for Feb. 22 - 26, 2010

FDA, Industry Discuss Challenges to 510(k) Program. At a recent workshop convened by FDA, the device industry stressed that FDA should not overhaul the 510(k) program—the regulatory pathway through which 90% of medical devices enter the market. The workshop sought to identify current challenges facing the 510(k) program and obtain industry and stakeholder input as to how to address these challenges. FDA staff raised specific issues for discussion, including the selection and use of predicate devices in the 510(k) process, how to deal with incremental changes to devices cleared for marketing through the 510(k) process, and FDA’s postmarket authority with respect to 510(k) devices. While high-level FDA staff say the agency is not announcing changes to the 510(k) program yet, many observers suspect FDA will implement policy changes to address the challenges identified at the workshop.

Industry Calls for Higher Payments for New Technologies. In a town hall meeting at the Centers for Medicare and Medicaid Services (“CMS”), device industry trade groups called on CMS to change how it reimburses health providers for the use of new technologies. Specifically, AdvaMed and the Medical Device Manufacturers Association urged the agency to increase new technology “add-on payments,” which are added to what CMS would typically reimburse for a procedure or treatment, in an attempt to cover the extra costs incurred by providers for using new technologies. Currently, add-on payments amount to 50% of the difference between the cost of the procedure and what CMS typically pays for that procedure; industry groups are calling for the agency to increase that amount to 80% of the difference.

FDA Seeks to Reduce Radiation from Imaging. In response to recent findings that medical imaging is on the upswing, FDA has announced new safety requirements for a variety of medical imaging techniques in an effort to reduce patient exposure to radiation. Specifically, fluoroscopic and nuclear imaging, as well as computed tomography and positron emission tomography, will be affected by the new requirements. The announcement comes on the heels of a CDC report that the use of imaging in hospital emergency rooms increased four- to five-fold between 1996 and 2007. Manufacturers of medical imaging equipment have expressed their support for the new requirements.

Weekly Device Summaries for Feb. 15 - 19, 2010

510(k) Task Force Convenes Comparative Effectiveness Meeting. As part of its ongoing effort to identify ways to improve the 510(k) program, an FDA task force recently met with stakeholders to address the role of the agency in comparing medical devices during premarket reviews. At issue was whether and how the agency should compare one device to another, particularly when assessing whether a 510(k) submission for a new device has demonstrated substantial equivalence to a previously cleared device. While consumer advocates maintained that new devices should become the “gold standard,” as opposed to older predicate devices, industry representatives expressed concern that such an approach could limit predictability in premarket reviews. Comments on this issue will be accepted by FDA until February 24, 2010.

Industry Calls for Exemption of Tests from FDA Review. Device industry trade group AdvaMed recently provided FDA with a list of 30 diagnostic tests that the group says should not be required to undergo premarket review by the agency. The list includes items such as blood tests for Epstein-Barr virus and parainfluenza, and it is part of an AdvaMed effort to change review of diagnostic tests by FDA. The group would like to exempt certain low-risk tests from FDA premarket review, while simultaneously expanding FDA regulatory oversight to tests developed by clinical labs, which are currently not regulated by the agency.

FDA Needs More Funding, Hamburg Says. FDA needs additional funds to make up for years of insufficient resources, Commissioner Margaret Hamburg said recently. Though the Obama administration’s proposed budget would increase FDA funding by 6%, the commissioner and others say this will merely allow the agency to continue current programming. According to Hamburg, the agency needs increased funding to improve its regulatory science resources to keep pace with emerging technologies. Premarket reviews of advanced products requires such scientific expertise at the agency, and the commissioner warned that without such expertise and resources, products could be inappropriately dismissed.

Weekly Device Summaries for Feb. 8 - 12, 2010

Obama’s Budget Would Create National Device Registry. In its recent budget proposal for fiscal year 2010, the Obama administration requested an additional $4 million for FDA’s device center, to fund the creation of a national device registry. The registry would involve the use of unique device identifiers (“UDIs”) and would seek to link these UDIs with patients’ electronic health data. The registry would be created and overseen by FDA, while device manufacturers would be required to place UDIs on their devices and health care providers would be tasked with gathering the patient-level data. Device industry trade groups generally support the proposed registry, noting that it is an improvement over previously proposed programs.

Medical Imaging Easily Reviewed on Handhelds. Radiologists can diagnose certain conditions just as well, if not better, with handheld devices such as iPods or personal digital assistants (“PDAs”), than with monitors typically used for viewing medical images. A recent study asked radiologists to review CT scans and X-rays of the wrist and brain both on a liquid crystal display monitor (which is typically used in clinical practice) and on an iPod or PDA. The study found that physicians diagnosed wrist fractures and brain hemorrhages just as accurately with the handheld devices as the larger monitors. The study authors said that the results could be expected to hold true for other types of medical images with similar properties.

Lack of Insurance Hinders Colorectal Screening. According to a National Institutes of Health (“NIH”) panel, whether a patient undergoes colon cancer screening depends largely on whether the patient has health insurance and access to a regular health care provider. As noted at a recent NIH conference on the issue, screening rates are as low as 20% for the uninsured, compared with 45-55% for those with public or private health insurance. The high cost of the procedure ($1,500-$3,000 for a virtual colonoscopy) renders it prohibitive for many uninsured, but conference attendees added that confusing screening guidelines are also to blame. Guidelines from cancer, radiology, and preventive health care groups vary and often conflict, according to attendees.

Weekly Device Summaries for Feb. 1 - 5, 2010

FDA Will Hold Public Meeting on 510(k) Pathway. FDA recently announced it will hold a public workshop about strengthening the review process for premarket notifications (“510(k) submissions”) for medical devices. At the meeting, FDA plans to address specific issues such as whether devices cleared through the 510(k) pathway should be required to show clinical utility and whether the agency should require post-market studies of 510(k) devices. Additionally, the meeting will address the use of combination predicates in 510(k) submissions and whether the current FDA database of previously cleared devices provides firms with enough information to accurately identify predicate devices. The meeting will be held on February 18, 2010, but FDA will accept comments on its proposed issues for discussion until March 5, 2010.

Industry Seeks Streamlined Event Reporting for Combination Products. FDA’s recently proposed requirements for reporting of adverse events stemming from combination products is still too complicated, drug and device firms maintain. Though the agency’s proposed rule sought to streamline regulatory requirements for combination products, which can be subject to multiple sets of regulations, industry representatives say the proposed rule needs further simplification. Specifically, firms take issue with FDA’s requirement that each company involved in making a product must report every event. Industry groups say that only the company holding the regulatory application for the finished combination product should be responsible for reporting an event.

Workshop on Interoperable Device Systems Raises Difficult Regulatory Pathway Questions. A workshop dedicated to regulating interoperability in the realm of medical devices was recently hosted by FDA. The agency sought feedback from industry and information technology specialists as to how to address medical and other devices that claim to be interoperable with other medical devices or medical systems. For example, attendees at the workshop discussed medical devices that link to electronic medical records, or even cell phones with applications that are designed to help patients manage their health. The workshop, which was co-sponsored by FDA, the Center for Integration & Innovative Technology (CIMIT) and Continua Health Alliance, will be followed by a report on the meeting and a roadmap of next steps.

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