Category: Standards

Standards

FDA Gets Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Breakdown

The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.

Standards

FDA Clears Linear Health Sciences’ Safety Release Valve

Linear Health Sciences received U.S. FDA clearance and Health Canada approval of its tension-activated breakaway safety release valve.

Standards

Medical Device Remanufacturing Is More Than Just a Job: Opinion

One member of the HTM sector believes that Congressional efforts to clarify the definition of medical device “remanufacturing” should be welcomed by all biomeds. He lays out his argument here.

Servicing Legislation

Colorado Set to Become First State with Right-to-Repair Wheelchair Law

The new bipartisan House bill would require medical OEMs to make parts, tools, and repair manuals available to powered wheelchair owners.

FDA Updates

FDA Drafts Guidance on Medical Device Voluntary Improvement Program

The U.S. FDA issued a draft guidance that is intended to describe its policy on its participation in the Voluntary Improvement Program.

Government Regulations

The Joint Commission Appoints New Chief Patient Safety Officer and Medical Director

The Joint Commission appointed Haytham Kaafarani, MD, MPH, FACS, as its new chief patient safety officer and medical director.

Cybersecurity

IMDRF Proposes Legacy Device Cybersecurity Guidance After Stakeholder Feedback

The IMDRF drafted a proposed guidance that seeks to protect legacy medical devices from cyberattacks.

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