AI

The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring. If...

As part of our blog series on Artificial Intelligence and Machine Learning Medical Devices, this time we will discuss the FDA’s take on how modifications made to the software after its initial review will be addressed within the SaMD pre-specifications and Algorithm Change Protocol submitted by the manufacturer to the FDA as...

As part of our blog series on artificial intelligence and machine learning driven medical devices, we discuss the SaMD Pre-Specification and the Algorithm Change Protocol that FDA has crafted for such devices, in this blog.  Before a medical device can be marketed in the U.S. it must be cleared or...

FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking great strides in establishing regulations for the digital health industry that also facilitates research and development while maintaining high quality products. In our previous blog: ARTIFICIAL INTELLIGENCE &...