Industry Attorneys: New Pre-Cert Model Vague On Requirement Details

Industry attorneys expressed concerns that FDA left out some important details in the second draft of its device precertification model, which outlines a potential new program where firms that meet certain criteria for organizational excellence could submit medical software products through a streamlined pre-market approval process. Lawyers said the new version, released Tuesday (June 19), is vague on exactly how FDA will appraise firms on an organizational basis rather than the usual, product-based approach, and how the agency will make...