News: October 17, 2007
CDRH is Considering New Guidance Documents for Development in Fiscal Year 2008. The U.S. Food and Drug Administration (“FDA”) published a notice in the Federal Register on October 10, 2007, directing the public to a list of guidance documents the Center for Devices and Radiological Health (“CDRH”) is considering for development in 2008. During recent negotiations over the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA), FDA agreed to annually post the list of the guidance documents that CDRH is considering for development and allow stakeholders an opportunity to provide comments and draft language for those topics, as well as suggestions for new or different guidance documents. The list includes topics that CDRH has identified as currently lacking any guidance associated with them, topics on which updated guidance may be helpful to industry, and topics for which CDRH has already issued drafts that will be finalized following a review of public comments. Interested persons are encouraged to submit comments to docket 2007N-0357. Additional information is available at http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html.
Congress Works on Technical Corrections Bill to Address FDA Trial Registry Requirements. According to device industry lobbyists, the new clinical trial registry requirements contained in the recently enacted FDA Amendments Act (“the Act”) are likely to be clarified in a technical corrections bill in the coming weeks. A significant and complex provision of the Act greatly expands the requirements for submitting information to the National Institutes of Health's (“NIH”) ClinicalTrials.gov database. Although unable to confirm what specific language might be altered in a technical corrections bill, House and Senate staffers have indicated that the entire bill will be scoured for technical and other needed changes. Under the Act, device manufacturers are required to submit to NIH for public posting basic information, including a brief summary of each pivotal trial, the primary purpose of the trial, the study design, the patient eligibility criteria and a host of additional basic descriptors, for all 510(k) Notice, Premarket Approval, or Humanitarian Device Exemption pivotal-phase trials. However, this information will not be made publicly available until after the product is cleared or approved to avoid premature release of trade secrets. Device manufacturers will also be required to submit basic results from these trials, including primary and secondary endpoint outcomes, and identify a contact person who can provide the public with additional information. Additionally, the Department of Health and Human Services (HHS) is required to issue regulations for including specific adverse events from trials in the database within 18 months. The corrections bill will include language clarifying that device trials are subject to the adverse event requirements of the Act. The word "devices" was inadvertently left out of this section. However, questions remain regarding how and when adverse events will need to be reported to the registry. Additional information is available at www.thegraysheet.com (paid subscription service).
CDRH Uses Cutting Edge Software Analysis Tools. In the past, software has been a difficult technology for FDA reviewers to assess because it is virtually impossible to test every eventuality that the software could lead to. However, the CDRH's recently upgraded “software forensics lab” now uses high-power instruments and techniques—routinely used in automotive and aeronautical industries—to analyze source code. In the past year, CDRH has used these tools to examine roughly a half dozen medical devices whose software was thought to be responsible for causing serious adverse events. These upgrades represent a substantial financial and time commitment by CDRH to get at the root cause of many of the most troubling postmarket device software failures. The agency hopes that this change will prompt manufacturers to use static analyzers in their future software development processes to prevent dangerous anomalies before their products hit the market. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA Calls For Additional Postmarket Study for Drug-Eluting Stent. FDA's Circulatory System Devices Panel has conditioned approval of Medtronic’s Endeavor zotarolimus-eluting stent on the performance of an additional postmarket study to monitor late stent thrombosis and to help determine an appropriate antiplatelet drug regimen for drug-eluting stent patients. FDA believes that the study, which must enroll at least 5,000 patients for five years, will help to shape the future of health care in the United States by encouraging manufacturers to obtain this sort of prospective safety data. FDA is also requiring that Medtronic specify a 12-month regimen of dual antiplatelet therapy for patients at low risk of bleeding, in accordance with the recommendations of cardiology professional societies, and include this information in Endeavor’s instructions for use. Additional information is available at www.thegraysheet.com (paid subscription service).
Significant Decreased in Inpatient Mortality Attributed in Part to Better Technology. recently reported a significant decrease in mortality rates for certain inpatient procedures. The agency reports that deaths from abdominal aortic repair, hip replacements, percutaneous coronary angioplasty have been dramatically reduced, as has the inpatient mortality rate for heart attack and stroke. AHRQ attributes the improvements to a variety of factors including the implementation of new treatments and better technology. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA Oversight of Clinical Trials Needs More Muscle. According to a September 28 report from the Health and Human Services Office of Inspector General (“OIG”), the Food and Drug Administration (“FDA”) lacks the data needed to protect patients enrolled in clinical trials. The report criticizes FDA for having too few Bioresearch Monitoring (“BIMO”) investigators and for only visiting 1% of clinical test sites during Fiscal Years 2000–2005. FDA claims that it is already introducing changes through its Human Subject Protection/Bioresearch Monitoring modernization initiative, begun in 2004. Although FDA believes it is off to a good start, OIG suggested five initiatives to improve FDA’s clinical trial oversight, including: (1) develop a comprehensive internal clinical trial database; (2) create an IRB registry; (3) establish a cross-center database to track all BIMO inspections; (4) provide feedback to BIMO investigators on their inspection reports and findings; and (5) seek expanded legal authority to oversee a clinical investigator’s colleagues and subordinates if they participate in conducting a trial. FDA claims it is already working on these recommendations and notes that FDA’s clinical trial registry will be internal and distinct from the National Institutes of Health (“NIH”) clinical trial registry called for in the recently enacted FDA Amendments Act. Additional information is available at www.thegraysheet.com (paid subscription service).
FDA Clears OmniWave ™ Endovascular System For Clot Removal In Peripheral Blood Vessels. OmniSonics Medical Technologies, Inc., recently announced that it has received clearance from the U.S. Food and Drug Administration to market its catheter based OmniWave™ Endovascular System. The system employs patented OmniWave™ Technology, the first minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus quickly, safely, and effectively. The OmniWave™ Endovascular System can be used for the infusion of physician specified fluids, including thrombolytics, and for the removal of thrombus in the peripheral vasculature. Additional information is available at www.medicalnewstoday.com.
Japan’s Device Payments Will Continue to Decline. Despite recent talks between U.S. and Japanese trade representatives yielding commitments from Japan to work to improve medical technology access and consult with the device industry about its pricing policies, current pressures on reimbursement in Japan are not expected to cease any time soon and additional payment cuts for medical devices are expected in 2008. According to a top Japanese health official, the Japanese government is likely to expand its practice of foreign average pricing and to continue payment reductions in response to its own economic realities. Reduced reimbursement, along with regulatory impediments or possible delays render the environment generally unfavorable for medical device innovation. This is potentially upsetting news for the U.S. medical device industry, which largely views Japan as an untapped market hindered by government barriers. Government officials acknowledge Japan’s “device lag” when compared with the rest of the advanced world and claim that the government is trying to make med-tech investment more attractive. To that end, top Japanese officials urge industry not to ignore the extreme domestic pressures in Japan, including the difficulty in persuading the Japanese people to accept much higher prices than those found in neighboring countries. Additional information is available at www.thegraysheet.com (paid subscription service).
MRI Is More Sensitive at Detecting Early Signs of Breast Cancer Than Mammography. According to a recent study published in The Lancet, MRI is much more sensitive than mammography for detecting breast cancers before they have developed to an invasive stage and is particularly good at identifying those lesions that are more likely to progress to dangerous forms of cancer. These findings are in stark contrast to previous studies that compare the two techniques, which have concluded MRI can not detect early cancers as effectively as mammography. Mammography is adept at detecting microcalcifications, small areas where cells have died and subsequently turned into calcium deposits, which are used as a hallmark of cancerous growth, whereas MRI is not. However, scientist have discovered that MRI can detect the growth of new blood vessels around the cancerous cells. Furthermore, MRI is able to distinguish between high-grade and low-grade subsets of ductal carcinoma in situ. These classifications refer to the likelihood of these lesions progressing to invasive breast cancer, in which the cancerous cells break out of the ducts and invade surrounding breast tissue. Additional information is available at www.medicalnewstoday.com.