Category: Standards

Standards

FDA Releases White Paper on Cybersecurity in Medical Manufacturing

New white paper highlights the need to secure operational technologies used in medical product production.

Standards

Baxter Issues Correction for Novum IQ Infusion Pump Over Underinfusion Risk

The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.

Standards

HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan

The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.

Servicing Legislation

Air Force Secretary Backs Right-to-Repair in Military Contracts

A Senate hearing highlighted support for right-to-repair in defense contracts, citing benefits like faster repairs, greater flexibility, and reduced contractor dependence.

FDA Updates

FDA Plans Agency-Wide AI Rollout Following Scientific Review Pilot

The FDA will expand generative AI tools across all centers by June 30 following a successful scientific review pilot, aiming to reduce repetitive tasks and improve operational efficiency.

Government Regulations

Tariff Pressures May Be Driving Advance Buying of Elective-Use Medical Devices

New data indicate increased spending on certain medical devices, though trends vary across procedures.

Cybersecurity

Systemwide Outage at Kettering Health Tied to Cyberattack

Kettering Health is investigating a cybersecurity incident that disrupted its systems.