The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.Read More

Company:Soft Computer Consultants, Inc.Date of Enforcement Report 8/9/2017 ClasslI: PRODUCT SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Recall Number Z-2865-2017 REASON Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent...Read More