FDA Slammed for & #039;Hiding & #039; Device-Related Injury Reports

An investigative report claims FDA is hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program. Kaiser Health News reported that at least 1.1 million incidents have been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE. The Kaiser report focuses on the obscurity of the practice, which was created nearly 22 years ago, as MD+DI reported at the time. Back in 1997, FDA urged manufacturers of 12 types of medical devices to request permission to submit only summary reports of well-known and well-documented events in lieu of routine MDRs. Those 12 device categories included various types of catheters, mechanical heart valves, breast implants, and pacemaker electrodes. Death reports have never been eligible for the program. The ASR program now includes about 100 medical devices, according to the Kaiser report. The investigation also uncovered records showing more than 480,000 injuries or malfunctions that were reported through the ASR in 2017 alone. FDA's Explanation of the Summary Reporting Program Stephanie Caccomo, an FDA spokesperson, told MD+DI that the agency issued a guidance document about the program in October 2000 that is still publicly available and solicited public comments on the document required by law. FDA modified the conditions of ASR exemptions in 2017 to include the submission of Form 350...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news