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Weekly Device Summaries for Dec. 28, 2009 - Jan 1, 2010

FDA Seeks Feedback on Incorporating New Science.  FDA will hold a public meeting on February 9, 2010 to address methods for incorporating new scientific advances into its regulation of medical devices, according to a recent Federal Register notice.  The Center for Devices and Radiological Health is convening the meeting to identify a predictable model for adapting the regulatory process to account for novel technologies or new uses of existing technology.  According to the Center, new science has often been addressed in regulatory decisions on an “ad hoc” basis, which has led to inconsistencies in the review of marketing applications for devices.  Public comments on specific questions to be addressed at the meeting will be accepted through February 24, 2010.

Infection Surveillance Saves Money, More Data Needed on Rapid Tests.  Screening high-risk patients for hospital-based infections can produce significant cost savings, according to experts and hospital case studies.  However, it is not clear whether using rapid tests to confirm infections contributes significantly to the success of such programs, as opposed to other program components such as improved hygiene and hand washing.  Hospitals utilizing rapid tests as part of infection surveillance programs have seen significantly reduced infection rates and cost savings, yet studies to evaluate the specific impact of the tests are ongoing. 

Researchers Claim Medical Device Studies Not Robust.  In a recent study, researchers analyzing studies used to support FDA approval of medical devices contend that such studies often were lacking in rigor.  The researchers argue that medical device trials should be more robust than drug studies, particularly for implantable devices.  Jeffrey Shuren, acting director of the Center for Devices and Radiological Health at FDA, however, says the agency has “serious concerns” regarding the approach used by the researchers and notes that the study made “inappropriate assumptions” about designing medical device studies.  Additional information is available at www.bloomberg.com.

Weekly Device Summaries for Dec. 21-25, 2009

FDA Says Not to Rely on Previous Decisions for 510(k) Submissions.  FDA will not necessarily abide by its past decisions on medical device premarket clearance (“510(k)”) submissions when reviewing new 510(k) submissions, officials said at a recent meeting.  Though device firms have typically relied on FDA’s regulatory requirements for similar, already cleared products when designing clinical studies and marketing applications for their products, FDA says these past decisions, if not in the best interests of public health, should not be used as a guide for future submissions.  FDA is seeking to improve the 510(k) process, which has come under fire in the past year, and is considering restructuring the agency so that all 510(k) submissions are reviewed by one team, in order to ensure predictable and consistent standards are applied to each submission.

Panel Recommends Randomized, Controlled Trials for Prostate Cancer Devices.  According to an FDA advisory panel, device firms designing clinical trials of new prostate cancer devices should utilize a randomized, controlled design with “watchful waiting,” sometimes called active surveillance, as a control.  At a recent meeting, the panel of clinical experts rejected the notion that nonrandomized designs could be used for trials of prostate cancer devices, despite the challenges involved in utilizing a randomized design.  Often, active surveillance has not been considered an acceptable control in prostate cancer trials, except in certain patient populations with short life expectancies. 

Weekly Device Summaries for Dec. 14-18, 2009

Device Industry Groups Lobby for Modifications to Device Tax.  With Congress likely including a sector-wide tax on the device industry in final health reform legislation, trade groups have joined forces to ensure the proposal adequately protects small device firms.  The current proposal involves a $20 billion fee on the industry as a whole, to be collected over 10 years, beginning in 2010.  Firms with revenues below $5 million would be exempt, and firms earning between $5 million and $25 million in revenues would pay a fee based on half of those revenues.  Device industry groups, however, are urging passage of an amendment that would exempt firms with revenues below $100 million and count only half of revenues between $100 million and $150 million toward the fee. 

Firms Give Advice on eMDR Submission.  Drug and device companies that have already submitted electronic medical device reports (“MDRs”) to FDA suggest that other firms experiment with electronic reporting before the agency transitions to an all-electronic system.  FDA soon will require all firms to submit MDRs electronically, via new tools available on the agency’s website.  Experienced submitters suggest that companies begin familiarizing themselves with the eSubmitter software and Web Trader program, which are suggested for firms that submit 50 or fewer MDRs per month.  Though firms submitting a higher volume of MDRs can eventually use other software, the early adopters recommend that all companies learn FDA’s low-volume tools before implementing full-scale electronic MDR reporting.   

UDI Pilot Test Report Makes Recommendations to FDA.  An e-health contractor has released a report analyzing FDA’s pilot program evaluating the agency’s proposed unique device identifier (“UDI”) system.  FDA is seeking to implement a mandatory UDI system, which would require all device firms to utilize and track UDIs for their products.  After conducting a pilot program of the proposed system with six medical device companies, the report urges FDA to better explain its rationale for much of the information requested of device firms during UDI implementation.  The agency asked pilot companies to provide data on 47 product attributes, only 11 of which were required, leaving pilot companies “perplexed” about some of the requests and hard-pressed to find responses. 

Weekly Device Summaries for Dec. 7-11, 2009

Task Force Publishes Quality System Guidance.  The Global Harmonization Task Force, an international group of representatives from regulatory agencies and industry, has released guidelines for device firms that address corrective and preventive actions for quality system management.  The long-awaited guidelines outline a four-prong approach to corrective and preventive actions, which includes planning, measuring/analysis, improvement, and management phases.  The guidelines also discuss the difference between a corrective action and a preventive action, and how firms should determine which device nonconformities warrant which type of action.  Comments on the proposed guidance are due in five months. 

Patients Could See Benefits of Comparative Effectiveness Research Soon.  Comparative effectiveness research could translate into improvements in health care delivery in as little as five years, according to the director of the Office of Management and Budget (“OMB”).  In addition to the $1.1 billion allocated for comparative effectiveness research in the Obama administration’s recent stimulus plan, the health reform bills currently under debate in Congress would establish a comparative effectiveness research institute to fund and manage such research.  According to the OMB director, the research is needed because the United States is spending too much on treatments for which there may be no evidence of benefit. 

CMS to Reimburse for PET, When Used in Clinical Studies.  The Centers for Medicare and Medicaid Services (“CMS”) has proposed to pay for use of positron emission tomography imaging (“PET”) for identifying bone metastases, so long as the imaging is performed as part of a clinical trial.  Though CMS believes there is not enough evidence that PET leads to improved outcomes in this area, the agency says that using PET in clinical studies could help bolster the evidence.  Specifically, CMS is seeking information regarding the degree to which PET informs initial treatment decisions and subsequent strategies for combating bone cancer.  To qualify for payment under the program, studies will have to meet rigorous criteria outlined by CMS.