First Post-FDASIA De Novo Guidance Offers Explicit Presubmission Reqs

Industry will likely be pleased with a new "straightforward" guidance describing how the de novo classification process will work under changes mandated by the FDA Safety and Innovation Act, although there are questions about the extent of information firms will need to submit to prove there is no predicate for a device, an industry attorney said. Another source noted that FDA had already informally implemented many of the changes and while the agency appears to be more comfortable with the...