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.
You may also be interested in...
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.