The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.Read More
"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.