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.
