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Found 2 result(s) for "FDA".

Showing 1-2 of 2 published article match(es)

publicFDA · USA · Updated Jun 4, 2026

FDA Final Guidance on Postapproval Requirements and Resources for ANDAs

Review the guidance to ensure compliance with post-marketing safety reporting timelines and annual report submissions; update SOPs for ICSR processing and periodic report generation.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact3 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV

verifiedRegulatory action: Guideline

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publicFDA · USA · Updated Jun 5, 2026

FDA Intent to Exempt Certain Unclassified Medical Devices from 510(k) Requirements

Urgency: Low

Identify which unclassified medical devices are affected by the exemption; update regulatory submissions and post-market surveillance plans accordingly; ensure compliance with general controls and post-market surveillance obligations.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceLow

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guideline

Read impact briefarrow_forward

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