PGT-A using human in vivo - Part 1 & 2

The FDA has published two attachments, labeled Part 1 and Part 2, detailing the first instance of Preimplantation Genetic Testing for Aneuploidy (PGT-A) conducted using human in vivo methods. These documents, authored by the Center for Drug Evaluation and Research (CDER), appear to be supplementary materials or case studies related to this specific application of PGT-A.

While these attachments do not appear to introduce new regulatory requirements or deadlines, compliance officers in the pharmaceutical and medical device sectors should be aware of their availability. They may be relevant for understanding evolving methodologies in genetic testing and their potential implications for clinical research and development oversight within the FDA's purview. No immediate actions are required based on this notice.