Apply to the ABMS Visiting Scholars Program
ABIM
MARCH 27, 2025
The Program begins in September 2025 and concludes at the ABMS Conference in September 2026. ABMS Visiting Scholars are selected based on the quality of their proposed research project.
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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
FDA Law Blog
SEPTEMBER 22, 2024
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. SCF : LDT, unmet need within an integrated healthcare system.
Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog
JULY 7, 2024
FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.
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