FDA Medical Device Labeling Requirements

Checklist
This is an extra resource to go along with the original article:
Am I Complying with FDA Medical Device Labeling Requirements?

Check box if
Regulatory requirement reference
you comply

General Device Labeling - 21 CFR Part 801

Use of Symbols - 21 CFR Part 801.15

In Vitro Diagnostic Products - 21 CFR Part 809

Investigational Device Exemptions - 21 CFR Part 812

Unique Device Identification - 21CFR Part 830

Good Manufacturing Practices - 21 CFR Part 820

General Electronic Products - 21 CFR Part 1010

© 2021 Greenlight Guru | Medical Device QMS Software

Greenlight Guru is the only quality management software designed specifically for medical device companies to bring
safe, true quality products to market faster. The cloud-based solution serves as a single source of truth by connecting
all quality processes to streamline team and work efficiency throughout the lifecycle of a medical device.