FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...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.