FDA is entering the test phase of its Digital Health Precertification (Pre-Cert) Pilot Program. General information on this program can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm including FAQs at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm577330.htm Milestones and next steps can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.htm Generally, this program is for some of what FDA refers to as Software as a Medical Device (SaMD). ...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.