FDA Oversight Of Medical Products Remains A "High-Risk"

Reprint Article From “The Gray Sheet” 2“We are aware that the agency has been taking a number of steps,” Crosse said. But of the remaining 20-some pre-amendment device types that FDA has yet to address, “only one final regulation has yet beenissued,” she noted, on dental amalgam.Crosse said she is scheduled to testify before Congress this week to provide an update and assessment onFDA’s progress since 2009.Getting Off The High-Risk ListTo get itself off the high-risk list, GAO says, FDA must respond more vigorously to the identifiedweaknesses, such as by establishing a plan and timetable for assuring that high-risk medical devices arereviewed through the PMA process, rather than 510(k).GAO removes the high-risk designation when legislative, administrative and agency actions result insignificant progress toward resolving identified issues.FDA must demonstrate a commitment to addressing the problems, a capacity to address them and acorrective action plan, Crosse noted.“It’s in our interest and in the interest of every person in this room that FDA have the capacity, theplanning, the direction and the ability to manage its responsibilities to protect the public health,” she toldFDLI meeting attendees.FDA’s oversight of food safety also made GAO’s high-risk list this year. The high-risk list includes 30items in total, spanning numerous government agencies.The biennial “High-Risk” report is part of a GAO program to focus attention on government operations thatthe office identifies as high risk “due to their greater vulnerabilities to fraud, waste, abuse andmismanagement, or the need for transformation to address economy, efficiency or effectivenesschallenges,” GAO explains.“Perseverance by the executive branch in implementing GAO’s recommended solutions and continuedoversight and action by Congress are essential to achieving progress,” the report states.By Jessica Bylander© 2011 F-D-C Reports, Inc.; An Elsevier Company, All Rights Reserved.Reproduction, photocopying, storage or transmission by magnetic or electronic means is strictly prohibited by law.Authorization to photocopy items for internal or personal use is granted by F-D-C Reports, Inc., when the fee of $25.00per copy of each page is paid directly to Copyright Clearance Center, 222 Rosewood Dr., Danvers, MA 01923, (978) 750-8400. The Transaction Reporting Service fee code is: 1530-1214/11 $0.00 + $25.00. Violation of copyright will result inlegal action, including civil and/or criminal penalties, and suspension of service. For more information, contactcustcare@elsevier.com.Reprinted with permission from “The Gray Sheet.” Unauthorized photocopying prohibited.