Stutzman: FDA Guidance Misinterprets FDASIA Custom Device Definition

A House Republican is echoing industry concerns that FDA draft guidance that would impose a five unit cap on the number of customized devices made by a single manufacturer yearly could block patient access to care. Rep. Marlin Stutzman (R-IN) recently urged FDA to revise the guidance on the custom device premarket exemptions that he said narrows the definition of a customized device and deviates from the legislative intent of the FDA Safety and Innovation Act. FDA said in guidance...