The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on recent FDA proposals to streamline the 510(k) and PMA submission processes and the ongoing investigation into FDA surveillance of CDRH employee whistleblowers.
The US Food and Drug Administration (FDA) is proposing new acceptance criteria for 510(k) submissions with the goal of improving overall review times and enhancing the quality of submissions.
A draft guidance released August 10th, “Refuse to Accept Policy for 510(k)s,” modifies guidances from 1993 and 1994 by adding a quick, early-review process for FDA to determine that a...
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
