RAPS

FDA Finalizes Electronic Medical Device Reporting Rule

A final rule promulgated by the US Food and Drug Administration (FDA) will require medical device manufacturers and importers to submit adverse event reports to the agency through a specific ...
RAPS

FDA finalizes guidance on reporting medical device shortages

FDA finalizes guidance on reporting medical device shortages The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical ...
Los Angeles Times

The Life-or-Death Stakes of Medical Device Cybersecurity

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...