FDA Regulatory Requirements for Home-Collected STI Nucleic Acid Detection Systems
Stay ahead in medical device compliance with this focused training on the FDA’s new Class II classification and special controls for systems that detect nucleic acid from non-viral microorganisms causing sexually transmitted infections (STIs) using home-collected specimens. Learn regulatory pathways, labeling standards, sample collection validation, and the documentation needed for 510(k) submissions. Gain practical insights for manufacturers and sponsors to meet FDA obligations and avoid costly enforcement actions.
In this course you will learn the following:
* Understand the scope and intent of the FDA’s classification and special controls for these diagnostic systems.
* Identify the key regulatory requirements and special controls now enforceable by law.
* Implement actionable steps to ensure compliance with the new rule.
* Recognize the legal and financial consequences of failing to comply with the final order.
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”.
