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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. While a removal requires physical removal from the point of use, a correction does not.

Manufacturing

Manufacturing Electronics Provider Management

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

FDA Law

JULY 7, 2024

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.

Manufacturing

Manufacturing Provider Physicals Electronics

Primary Care Digest

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

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

Webinars

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