The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety/effectiveness, or when a series of lesser changes finally reach the "tipping point".
This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
John E Lincoln
