CIMIT: March 2008 Regulatory Affairs Newsletter

March 2008 Regulatory Affairs NewsletterPrint this page

• CDRH Director Alludes to an Increase in510(k) Data Requests for Certain Devices
• FDA Investigates Effect of Radio Interference on Implantable Devices
• Legislators to Introduce Preemption Amendment
• Medicare Competitive Bidding May Save Billions
• Third Wave’s Cystic Fibrosis DNA Test Gains FDA Approval
• Device Industry Experts Warn of FCPA Investigations
• PMA Preemption Unclear for Combination Products
• FDA Publishes Updated Guidance on Expedited Review
• FDA’s Radiological Devices Advisory Panel Recommends Testing of
Concurrent and Sequential Mammography CAD
• GAO: Reprocessed Single-Use Devices Are Safe
• Device Expert Calls for More Consumer Protection
• FDA Science Board Calls for Budget Increase
• FDA Looking to Open International Offices
• Standard Template for Recall Press Releases Proposed
• FDA Approves Amniotic Fluid Detection Device
• FDA Genetic Test Oversight to Increase
• Lawmakers Threaten to Overturn Supreme Court Preemption Decision
• Device Industry Looks to Civil Settlements for Compliance Standards

CDRH Director Alludes to an Increase in510(k) Data Requests for Certain Devices
According to CDRH Director Daniel Schultz,M.D., FDA will be demanding more comprehensive data in support of certain premarket notifications (“510(k)”). Today, 95% of medical devices are cleared for market through the 510(k) pathway. However, many of the devices that are cleared via 510(k) are approaching the dividing line between devices that may use the 510(k) process and those that require premarket approval (“PMA”). In cases where the device under review is distinguishable from the claimed predicate device in terms of technology or indications for use, the agency will be asking for as much data as it deems necessary to determine substantial equivalence—even if that means that some may feel the bar has been raised. Schultz cautions that with today’s increases in technology, expecting the regulatory system to be unchanged from 1976 is untenable. Additional information available at www.thegraysheet.com (paid subscription service).

FDA Investigates Effect of Radio Interference on Implantable Devices
As radiofrequency fields become more prevalent in hospitals and other public spaces, scientists are concerned that energy waves from radiofrequency identification (“RFID”) systems could affect the performance of implantable devices, such as pacemakers and defibrillators. Although FDA has received a number of incident reports related to electromagnetic interference of cell phone and other non-medical technologies, the RFID issue is fairly new. Testing conducted in 2006 lead to the release of a new AAMI/American National Standard in November 2007. The agency continues to investigate the electromagnetic characteristics that may be interfering with implantable devices and will use the data generated to improve current EMC standards for pacemakers and implantable cardioverter defibrillators. Additional information is available at www.thegraysheet.com (paid subscription service).

Legislators to Introduce Preemption Amendment
Legislators in the House of Representatives intend to introduce legislation that aims to ensure that federal law does not preempt state law products liability claims brought by people harmed byfaulty medical devices. The draft Medical Device Safety Act of 2008 is a response to the Supreme Court’s recent decision in Riegel v. Medtronic, in which the court held that the express preemption provision of the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempts state law claims for damages based on injuries resulting from a device that has been approved through FDA’s premarket approval (“PMA”) process. The draft legislation seeks to add language stating that the FDCA cannot be construed to modify or affect the liability of any person under state law. Additional information available at www.fdanews.com or www.thegraysheet.com (paid subscription service).

Medicare Competitive Bidding May Save Billions
According to CMS, Medicare’s new competitive bidding program for durable medical equipment may save the program and its beneficiariesone billion dollars in 2009. In 2008, the new competitive bidding program will operate in ten metropolitan statistical areas (“MSA”) and will apply to ten product categories. The program is expected to extend to 70 MSAs in 2009 and will continue to increase in future years. The program, which was mandated by the 2003 Medicare law, is part of a larger effort to implement competitive bidding for CMS reimbursements. The program is scheduled to take effect on July 1, 2008, and is expected to result in an average26% decrease in the price of medical equipment in the 10 covered MSAs this year. Additional information available at www.medicalnewstoday.com.

Third Wave’s Cystic Fibrosis DNA Test Gains FDA Approval
Third Wave Technologies, Inc., recently gained FDA approvalfor its cystic-fibrosis DNA test. The test is designed to be administered to adults, children, and newborn infants to determine whether they carry the genes for cystic fibrosis. In studies submitted to FDA, the device was able to identify 100% of the samples tested that carried cystic fibrosis. Additional information is available at www.devicelink.com.

Device Industry Experts Warn of FCPA Investigations
According to legal experts in the medical device arena, device firms can expect to be increasingly scrutinized for violations of the Foreign Corrupt Practices Act (“FCPA”) in the near future. Although in the past, such investigations have focused primarily on pharmaceutical companies, device firms have recently found themselves the subject of so called “sweep cases,” by which the Securities and Exchange Commission (“SEC”) tests the overall compliance of the industry. As the U.S. medical device industry becomes increasingly global, device firms should expect that FCPA investigations will continue to increase. Additional information is available at www.fdanews.com.

PMA Preemption Unclear for Combination Products
Plaintiff’s lawyers are arguing that drug-device combination products should not be entitled to federal preemption under the Federal Food Drug and Cosmetic Act (“FDC Act”), because theFDC Actdoes not contain a similarprovision that grants federal preemption to pharmaceuticals. Thus, some claim that such combination products are not covered by the Supreme Court’s February 20, 2008, decision in Riegel v. Medtronic, which held that devices that are approved through FDA’s rigorous PMA approval process are entitled to federal preemption against products liability claims. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Publishes Updated Guidance on Expedited Review
FDA recently released an updated guidance document, “Expedited Review of Premarket Submissions for Devices,” which replaces the agency’s prior guidance on the subject and reflects the changes made by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The new guidance is available at www.fda.gov/cdrh/mdufma/guidance/108.html. Notably, under the new guidance, devices under expedited review from FDA will now retain that status, even if another device for the same indication is approved first. However, any application filed after the approval or clearance of a similar device will not be granted expedited status unless necessary for reasons of national security. Additional information is available at www.fdanews.com or www.thegraysheet.com (paid subscription service).

FDA’s Radiological Devices Advisory Panel Recommends Testing of
Concurrent and Sequential Mammography CAD
According to FDA’s Radiological Devices Advisory Panel, which met on March 4, 2008, the agency should require sponsors of computer aided detection (“CAD”) devices for mammography to test their devices with both concurrent and sequential reading approaches. Also among the panel’s conclusions is the recommendation that sponsors should provide to FDA details of the CAD algorithm used by their device. The panel’s recommendations will be used by the agency to develop a new guidance for industry on the FDA approval process for CAD. Additional information is available at www.thegraysheet.com (paid subscription service).

GAO: Reprocessed Single-Use Devices Are Safe
According to a March 3, 2008, report issued by the Government Accountability Office (“GAO”), FDA’s approach to regulating reprocessed single-use devices (“SUDs”) is adequate to protect the public from elevated health risks. The report states that no causal like has been established between reprocessed SUDs and reported injuries and deaths from device malfunctions. The current safety studies of SUDs indicate that these devices pose no greater safety threat than new, non-reprocessed SUDs. This is considered good news for device reprocessors, who point out that they represent the only segment of the U.S. device industry involved in reducing the cost of medical devices and reducing medical waste, while still providing the highest quality of medical care available. Additional information available at www.thegraysheet.com (paid subscription service).

Device Expert Calls for More Consumer Protection
According to William Maisel, M.D.,a leading expert on medical device safety and past chairman of FDA’s Circulatory System Devices advisory panel, Congress should compel FDA and manufacturers to provide more consumer protection for patients receiving implanted devices. According to Maisel's editorial in the March 6 issue of the New England Journal of Medicine, the welfare of medical device recipients is not a high enough priority for FDA and manufacturers. Indeed,manufacturers have an inherent financial conflict of interest when addressing device safety issues. Maisel has also called for FDA to balance the interests of manufacturers and patients during its review process by ensuring that every device is evaluated by an FDA reviewer specifically tasked with protecting patients’ interests. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Science Board Calls for Budget Increase
According to a recent report bythe FDA Science Board (the “Board”), the agency’s budget needs to double over the next five years. The report calls for a $375 million increase over fiscalyear 2008 in direct appropriations to FDA for fiscal 2009 and for additional increases in the following five years. The report explains that five-year cost estimates were provided because the Board recognizes the need for a phased-in approach, even though substantial new resources are needed immediately. The original report was entitled, “FDA Science and Mission at Risk” and identified FDA’s major weaknesses, highlighting gaps in scientific expertise and insufficient information technology. Although the Board was originally asked not to assess available resources, it quickly became apparent that the agency’s weaknesses are directly related to two decades of inadequate funding, making it impossible to assess one without also looking at the other. Additional information is available at www.fdalegislativewatch.com.

FDA Looking to Open International Offices
According to FDA Commissioner Andrew von Eschenbach, the agency needs to increase foreign inspections to adequately regulate products in the 21st century. Accordingly, he believes that the agency must increase risk-based inspections, increase collaborations with foreign partners, and establish offices in other countries. “FDA Without Borders” is a new agency initiative that aims to establish offices in at least five regions, beginning with China. FDA is also working with the State Department to establish offices in other regions, including India, the Middle East, Central America, and South America. At present, FDA is also developing a new system called Predict that will enhance the agency’s information gathering capabilities, allowing it to better identify where to allocate inspection resources. The agency plans to increase the overall number of inspections this year; to do so, FDA intends to hire 700 additional employees. Additional information is available at www.fdanews.com.

Standard Template for Recall Press Releases Proposed
FDA is proposing a new template for press releases on recalls of all products regulated by the agency, including medical devices. The forms are designed to ensure that manufacturers put recalls in the proper context, but offers some flexibility in the wording of such announcements. The new template would structure the information in a more useful way and would allow FDA to get safety recall information out faster. It includes sections for describing the problem, persons at risk, how to identify the product, where the product is distributed, what symptoms to look for, and who should be contacted. Insiders recommend that FDA remove the word “recall” from all public communications regarding implantable products out of concern that it confuses patients as to whether they need to have their devices explanted. Still, others are concerned that the word “recall” is necessary to adequately inform consumers of the nature of the situation. Additional information is available at www.medicaldevicestoday.com.

FDA Approves Amniotic Fluid Detection Device
Barr Pharmaceuticals recently announced FDA approval of its AmniScreen at-home test for amniotic fluid leakage during pregnancy. The device consists of a panty-liner embedded with a proprietary polymer-coated polyester strip that detects amniotic fluid leakage, which may indicate a problem during pregnancy. The device is the first of its kind to obtain FDA approval. Additional information is available at www.fdanews.com.

FDA Genetic Test Oversight to Increase
Industry insiders and government agency representatives are calling for FDA to review all diagnostic tests, including those developed by laboratories. Under current FDA policy, most lab-developed tests (“LTD”) sold as diagnostic services are not regulated by the agency. However, FDA consistently regulates in vitro diagnostic test kits, which are sold as packaged products. At its recent meeting, the Health and Human Services (“HHS”) Secretary’s Advisory Committee on Genetics, Health, and Society (“SACGHS”) announced that it will recommend that all such tests be addressed, if not regulated, by the agency. While agency officials agree that FDA has the authority to regulate these tests, many are skeptical about whether the agency has the resources to handle the task. Additional information available at www.thegraysheet.com (paid subscription service).

Lawmakers Threaten to Overturn Supreme Court Preemption Decision
The U.S. Supreme Court (“the Court”) recently decided Riegel v. Medtronic, ruling 8–1 that the express preemption provision of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) preempts state-law claims seeking damages for injuries caused by devices with FDA approval. Following the Court’s decision some Congressional leaders have called for legislative action to “correct” the courts decision. In particular, Sen. Edward Kennedy (D-Mass.) has called for lawmakers to overturn the Court’s decision through legislative action, warning that otherwise, “FDA approval will become a green light for shoddy practices by manufacturers.” Additional information available at www.fdanews.com.

Device Industry Looks to Civil Settlements for Compliance Standards
In the wake of the recent anti-kickback violation settlement of five orthopedic device manufacturers, companies are looking for judicial or statutory guidance to help them avoid legal trouble related to corporate sales practices. However, legal experts predict that medical device manufacturers may have to rely on previously negotiated settlements for guidance. To the extent that new “law” in this area is created, it is expected to come in the form of civil settlements, corporate integrity agreements, and other negotiated remedies. Deferred prosecution agreements, under which companies can avoid criminal prosecution by making reforms and submitting to monitoring, are also likely to become more common. Additional information is available at www.thegraysheet.com (paid subscription service).