Regulatory Insights & Updates

Medical Device Regulatory Resources

FDA Quality Management System Regulation (QMSR) Quality management requirements for medical device manufacturers aligned with ISO 13485 principles.

🔗 FDA QMSR Final Rule

Medical Device Reporting (MDR) Requirements for reporting device-related adverse events and malfunctions.

🔗 21 CFR Part 803 – Medical Device Reporting

🔗 FDA eMDR Program

Corrections and Removals Requirements for reporting field corrections and product removals.

🔗 21 CFR Part 806 – Corrections and Removals

Unique Device Identification (UDI) FDA UDI requirements and device identification resources.

🔗 FDA UDI System

🔗 AccessGUDID Database

Medical Device Labeling General labeling requirements for medical devices.

🔗 21 CFR Part 801

Electronic Records & Electronic Signatures Requirements for electronic records and signatures.

🔗 21 CFR Part 11

Food Regulatory Resources

FDA Food Facility Registration Requirements for domestic and foreign food facilities.

🔗 FDA Food Facility Registration

Foreign Supplier Verification Program (FSVP)

🔗 FDA FSVP Program

Food Labeling Requirements

🔗 FDA Food Labeling Guide

Preventive Controls for Human Food

🔗 21 CFR Part 117 – Preventive Controls for Human Food

Produce Safety Rule

🔗 FDA Food Traceability Final Rule

FDA Food Guidance Documents

🔗 FDA Food Guidance Documents

Quick Compliance Tools

🔗 AccessGUDI

🔗 FDA Registration & Listing

🔗 FDA Guidance Documents

🔗 Food Facility Registration

🔗 FSVP

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