FDA Eyes Changes to 510(k) Program

FDA wants to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. The agency said it is pursuing changes to the program in an effort to help keep pace with the increasing complexities of evolving medical technology. It's important to note that the Center for Devices and Radiological Health (CDRH) cleared 3,173 medical devices through the 510(k) pathway in 2017, representing 82% of the total devices cleared or approved by FDA. "The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging," said FDA Commissioner Scott Gottlieb, MD and CDRH Director Jeff Shuren, MD, in an agency statement issued Monday. "The framework we propose is aimed at efficiently advancing beneficial technology to patients while solidifying FDA’s gold standard for safety." The news comes at a time when the medical device industry and regulatory bodies like FDA are facing increased scrutiny from the public in light of mass media coverage concerning the safety of some types of medical devices. Most recently, an international consortium of investigative journalists published a harrowing report pointing to more than 1.7 million device-related patient injuries and nearly 83,000 deaths reported to FDA over the p...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news