Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Pipeline Safety: Class Location Change Requirements. Document Number: 2026-00566
Buy this Course
FR-26-1675-1
Medical Device QMSR Technical Amendments: Editorial Updates for FDA Compliance
$49.99
Stay current with FDA expectations by learning the details of the latest technical amendments to medical device regulations. This course explains the editorial updates that revise and standardize references in 21 CFR to align with the QMSR Final Rule, harmonizing with ISO 13485:2016. It clarifies what’s changed, what remains the same, and how to maintain compliance. Ideal for professionals responsible for regulatory submissions, quality documentation, or compliance in the device sector.
In this course you will learn the following:
* Understand the purpose and scope of the technical amendments to 21 CFR Parts 801, 803, 812, 860, and related device regulations.
* Identify the key changes made to regulatory references and terminology to align with the QMSR.
* Recognize the effective date and compliance expectations for the amended regulations.
* Appreciate the non-substantive nature of these amendments and their impact on compliance.
* Understand the consequences of non-compliance with existing requirements as clarified by the amendments.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Why This Course is Important
Without this course, you risk citing outdated regulations, creating compliance gaps, and facing potential delays or scrutiny during FDA reviews or inspections.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Quality Management System Regulation Technical Amendments.
Key regulatory references include:
- 21 CFR Part 801 – Labeling
- 21 CFR Part 803 – Medical Device Reporting
- 21 CFR Part 812 – Investigational Device Exemptions
- 21 CFR Part 860 – Medical Device Classification Procedures
- 21 CFR Part 862 – Clinical Chemistry and Clinical Toxicology Devices
Course SKU
FR-25-1622-1