December 9, 2025
The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances…Read More
October 19, 2023
It is encouraging to see the FDA’s Center for Devices and Radiological Health (CDRH) has signaled in their proposed guidances for fiscal year 2024 (FY2024) that guidances related to Artificial Intelligence/Machine Learning (AI/ML) are getting a high priority…Read More
