Disposables manufacturers urge FDA rethink on reuse rules
This article was originally published in Clinica
Executive Summary
Manufacturers of disposable devices are lobbying the US FDA to reconsider aspects of its new regulatory scheme for reused single-use devices. At issue is the agency's decision to exempt hospitals and third-party reprocessors from having to file a premarket submission for certain single-use class I or low-risk devices in order to reuse the product.