FDA Medical Device Safety Action Plan: Good or Bad for Medtech?

In April, FDA released a five-pronged Medical Devices Safety Action Plan, full of rhetoric aimed at convincing the public that this new plan will enhance the agency's commitment to patient safety and recognition that safety and innovation should go hand in hand. Some aspects of the plan call for new ways to use FDA's existing tools, while others identify areas where the agency "may need additional authority," according to FDA Commissioner Scott Gottlieb, MD. As with most draft guidance FDA puts forth, the release of the Medical Devices Safety Action Plan came with a public comment period, which ended Aug. 17. AdvaMed and Johson & Johnson were among the industry leaders that raised concerns with some of the specifics of the plan, as did the American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS). The following highlights five key areas of the plan, what Gottlieb has said about it, plus the specific concerns of AdvaMed, J&J, AANS, and CNS. 1. Establish a Robust Medical Device Safety Net in the U.S. Gottlieb: We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for Health Technology. NEST links data from registries, EHRs and billing claims. NEST will facilitate timely detection of potential safety risks that wouldn’t otherwise be identified as quickly, or at all. But it requires addressing variations in dat...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news