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 Medical Device Classification: Foam or Gel Chemical Sterilant/High Level Disinfectant
$19.99
Stay ahead in the medical device industry with this targeted training on FDA’s final rule for foam or gel chemical sterilant/high level disinfectants. Learn the specific requirements for Class II classification, including essential special controls, performance testing, labeling standards, and the 510(k) submission process. Gain step-by-step guidance for regulatory compliance, protecting both your business and patient safety while enabling market access for innovative infection control products.
In this course you will learn the following:
* Understand the new classification and regulatory requirements for foam or gel chemical sterilant/high level disinfectants.
* Identify the special controls and general controls applicable to these devices.
* Implement the necessary steps to ensure compliance with the final rule.
* Recognize the legal and financial risks of non-compliance.
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
Manufacturers and regulatory teams who skip this course risk costly compliance mistakes, delayed product launches, increased legal exposure, and potential denial of FDA market authorization for disinfectant products.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant.
Key regulatory references include:
Course SKU
FR-26-2039-1