Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Regulation Crypto Assets. Document Number: 2026-17183
Buy this Course
FR-26-2164-1
FDA Proposed Rule: Class I Classification for Distinct Medical Device Accessories
$19.99
Gain actionable knowledge on the FDA’s proposed rule to classify select medical device accessories as distinct from parent devices and eligible for Class I status, per the FDA Reauthorization Act of 2017. This training breaks down the regulatory background, the proposed list of qualifying accessories, and what manufacturers and healthcare professionals should know about the public comment process. Discover the implications for regulatory obligations and how to meaningfully participate before the rule is finalized.
In this course you will learn the following:
* Understand the goals and intent of the FDA’s proposed accessory classification rule.
* Identify the legal framework and criteria for distinct classification of medical device accessories.
* Recognize the proposed list of accessories suitable for Class I classification.
* Describe the process and importance of public participation in the rulemaking process.
* Acknowledge that the proposed rule is subject to change based on public comments.
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
Missing this course could result in overlooked opportunities for regulatory streamlining, non-compliance risks, and missed chances to influence FDA policy affecting accessory classification.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments.
Key regulatory references include:
- 21 CFR Part 870 – Cardiovascular Devices
- 21 CFR Part 876 – Gastroenterology-Urology Devices
- 21 CFR Part 878 – General and Plastic Surgery Devices
Course SKU
FR-26-2152-1