FDA Guidance on Laboratory Developed Tests: Additional Resources
The new article refers to additional resources to be taken into consideration by the parties involved in operations with laboratory-developed tests.
The new article refers to additional resources to be taken into consideration by the parties involved in operations with laboratory-developed tests.
The final article dedicated to Diversity Action Plans describes certain specific aspects pertaining to the matter, emphasizing the key considerations.
The new article pays special attention to the content of Diversity Action Plans, emphasizing the aspects related to the relevant goals.
The new article describes in detail the applicability scope and also outlines specific considerations for certain groups of patients that require special attention in order to ensure they are properly represented among study participants.
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...