AI

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...

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...

On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191....