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Apply to the ABMS Visiting Scholars Program

ABIM

The American Board of Internal Medicine (ABIM) is committed to enhancing the quality of health care by certifying internists and subspecialists who demonstrate the knowledge, skills and attitudes necessary for excellent patient care. The Program begins in September 2025 and concludes at the ABMS Conference in September 2026.

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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. report certain device malfunctions, and. establish and maintain adverse event files.” [9]