Closed consultations

A review of the NCAR system

Adverse Event Terminology

Good Regulatory Review Practices

IMDRF recognized standards

Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Medical Device Clinical Evaluation

Medical Device Cybersecurity Guide

Medical device single audit program (MDSAP)

Personalized Medical Devices (PMD)

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Regulated Product Submission

Software as a Medical Device (SaMD)

Unique Device Identification (UDI) Application Guide