Your virtual QARA manager for digital health and medical devices

HOME
KNOWLEDGE BASE
STAY INFORMED
TAGS
CATEGORIES
ABOUT

Home Tags Administration

Tag

Administration 1

Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT) Feb 2, 2024

Recently Updated

Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (DRAFT)
Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation (DRAFT)

Trending Tags

Medical Devices Premarket Biologics Drugs 510(k) Radiation-Emitting Products Administrative / Procedural Good Clinical Practice (GCP) Postmarket Labeling

© 2025 ReguVirta. Some rights reserved.

Using the Chirpy theme for Jekyll.

Trending Tags

Medical Devices Premarket Biologics Drugs 510(k) Radiation-Emitting Products Administrative / Procedural Good Clinical Practice (GCP) Postmarket Labeling

A new version of content is available.