CIMIT: April 2010 Regulatory Affairs Newsletter

April 2010 Regulatory Affairs NewsPrint this page

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

Weekly Device Summaries for April 26 - 30, 2010

FDA to Improve Regulation of Home Use Devices. FDA announced its new “home use” initiative on April 20, 2010, in which the agency will seek to strengthen oversight of medical devices intended for use in the home. Under the initiative, FDA will issue new guidance for manufacturers, which will describe what actions should be taken to obtain premarket approval or clearance of a home-use device. Additionally, FDA is recommending stronger post-market surveillance of these devices, and intends to publicly post the labeling of devices approved or cleared for home use. The initiative follows the agency’s receipt of more than 19,000 adverse event reports linked to home-use devices from 1997-2009.

EU to Institute Mandatory Centralized Device Database. The European Commission has decided to require all countries in the European Union (“EU”) to use a centralized database containing information on medical devices. The database, called Eudamed, is currently used voluntarily by EU member states and contains information on medical device manufacturers, certificates of conformance, clinical studies, and safety data. The database, which is not available to the public, would allow national competent authorities to rapidly share information, potentially leading to a more rapid and streamlined response to safety issues.

New Guidelines Issued for Research and Clinical Use IVDs. FDA announced new guidelines for in vitro diagnostic devices that have both a clinical diagnostic application and a research use. The guidelines aim to assist manufacturers of devices, such as those used to amplify DNA segments, that could be used both for laboratory research and for providing diagnostic information to patients. Currently, for some laboratory-only applications, these devices do not require FDA review or approval prior to use. Meanwhile, when the same devices are used to perform diagnostic tests and provide results to patients, the FDA must review the product prior to marketing and use. The guidelines provide strategies, such as creating two separate user manuals, that would allow companies to provide the devices for both uses.

FDA to Address Safety Problems Related to Infusion Pumps. FDA is ratcheting up the requirements for premarket submissions of external infusion pumps after receiving a high number of adverse event reports related to the pumps in recent years. On April 23, 2010, FDA sent a letter to pump manufacturers and issued guidance about the new requirements. The agency also plans to launch a website about the pumps and hold a meeting about infusion pump safety on May 25-26, 2010. In the past five years, more than 56,000 adverse event reports were linked to the devices, and more than 87 pumps were recalled.

Weekly Device Summaries for April 19 - 23, 2010

FDA Cooperation with Industry Decreasing, Groups Say. FDA staff are becoming increasingly hesitant to communicate with and work with industry, device industry groups contend in recent comments to the agency. The comments were submitted in response to an FDA request, as part of the agency’s Transparency Initiative. In the comments, industry trade group AdvaMed claims that the frequency of agency-industry interactions has decreased recently and that scheduling meetings and calls with the agency has become increasingly difficult. The Medical Imaging and Technology Alliance agreed that FDA poorly communicates with industry, and submitted comments with recommendations for improving agency-industry communications.

FDA May Increase Prosecution of Executives. In a recent letter, FDA Commissioner Margaret Hamburg stated that FDA intends to increase prosecutions of corporate executives under a rarely used doctrine. The “responsible corporate officer doctrine” allows the government to bring misdemeanor charges against corporate executives for having the authority to prevent, detect, or correct a company’s violation of the FDCA and failing to do so. Under this doctrine, the government does not need to prove that the executive played a role in the violation or had knowledge of the violation, making it difficult for officers to defend themselves. The doctrine has been infrequently invoked in recent decades, but recent cases against leaders of FDA-regulated companies indicates the agency may revive the doctrine.

Agency Advises on Use of Foreign Data in Premarket Submissions. At a recent regulatory conference, FDA officials advised device firms as to how to use clinical trials conducted abroad to successfully support a U.S. marketing application. According to the agency, FDA should review all clinical trial protocols prior to study initiation to maximize the chance that FDA will accept the company’s resulting study data. Additionally, device firms should seek this FDA input early in the study design process, even if the discussions could delay study initiation. Agency staff noted that these early communications, as well as frequent communications with FDA throughout the study, are integral to ensuring a smooth approval process.

Weekly Device Summaries for April 12 - 16, 2010

Online Tool Will Track FDA Performance. As part of a plan to increase transparency at the Department of Health and Human Services, FDA has released a new Web tool that will track FDA activities and performance in various areas. The tracking tool, available through the FDA website, will include a “Premarket Dashboard” that tracks the number of 510(k) decision summaries posted each month for in vitro diagnostic devices. The Web tool also monitors FDA’s progress in developing guidance for the device industry and includes a demo of a program for automating the 510(k) review process.

FDA Evaluating Review of Radiotherapy Devices. On April 8, 2010, FDA’s device center sent a letter to manufacturers of radiation therapy devices to discuss agency efforts to improve the safety of such devices. Since 1999, FDA has received 1,182 reports of adverse events associated with radiotherapy devices, mostly due to faulty design or user errors. The agency now is seeking to reduce dosage errors from the devices and is considering modifying the premarket review process for the devices to enhance safety. FDA may require premarket review for all software changes made to radiotherapy devices going forward, and the agency also may limit the use of abbreviated premarket pathways for these devices.

Personalized Medicine Provides Opportunity for Device Companies. A movement toward personalized medicine could be a “huge opportunity” for medical device and diagnostic firms, according to a recent PricewaterhouseCoopers survey. According to the report, an improved understanding of how personal factors such as genetics, behavior, and socio-economics impact an individual’s health will change the global health model in the coming years. This change presents opportunities for device companies to design personalized treatment delivery systems and personalized diagnostic tools. However, traditional reimbursement approaches may present a barrier to creating a new personalized medicine system, according to the report.

Weekly Device Summaries for April 5 - 9, 2010

FDA to Require Pediatric Information in PMA Submissions. Companies seeking premarket approval for medical devices will soon have to provide FDA with information on the potential pediatric use of their device. According to a final rule published March 31, 2010, FDA will require sponsors to include such information in all premarket approval (“PMA”) applications, beginning in August. Companies will be required to include information regarding pediatric populations that suffer from the disease for which the device is intended, as well as information on the number of pediatric patients who may be treated with the device. The rule seeks to implement requirements of the FDA Amendments Act of 2007.

Industry, Clinicians, FDA Seek to Reduce Radiation from Imaging. At a recent public meeting, FDA, physicians’ groups, and industry discussed methods for reducing radiation exposure from imaging modalities such as computed tomography (“CT”) and fluoroscopy. According to FDA, patients’ radiation from medical imaging has increased five-fold in the past 30 years, and CT and fluoroscopy represent the lionshare of this exposure. Representatives from the Medical Imaging & Technology Alliance expressed their support for reducing unnecessary exposure and highlighted an initiative underway by manufacturers to monitor radiation dosage during imaging and set standards for reducing overexposure and medical errors.

Judge Invalidates Breast Cancer Gene Patents. A federal court struck down patents on the two BRCA breast cancer gene patents on March 29, ruling that the patents were invalid. A New York judge ruled that DNA isolated from the body is unpatentable, because it is not markedly different from a product of nature, which cannot be patented. The judge also held that the mental act of comparing different DNA sequences and forms of the BRCA genes is not patentable because it is an abstract mental process. The ruling is the first to strike down patents covering isolated DNA, and the companies owning the current BRCA patents plan to appeal the decision.

Special Controls Proposed for Certain Device Types. In a proposed rule published April 5, 2010 in the Federal Register, FDA suggests amending regulations for 11 types of devices to establish special controls for the devices. The devices affected by the rule are largely class II neurological and physical medicine devices, and FDA has also issued draft guidance documents that describe the controls proposed to mitigate risks associated with the devices. The agency seeks to exempt six of the device types from 510(k) requirements, including electroconductive media, cutaneous electrodes, certain electrical nerve stimulators, and certain powered muscle stimulators. Comments on the proposed rule and the guidance are due by July 5, 2010.

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