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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. is it the lab itself, the healthcare provider, or the patient?).

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

FDA Law Blog

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

It then establishes a new Rural Physician Income Tax Credit program, effective January 1, 2026, that provides a $10,000 annual tax credit to qualifying rural physicians for up to four tax years. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

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