News: March 26, 2008
CDRH Director Alludes to an Increase in 510(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 by faulty 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 beneficiaries one 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 average 26% decrease in the price of medical equipment in the 10 covered MSAs this year. Additional information available at www.medicalnewstoday.com.