TREATMENT IDE RULE ALLOWS COST RECOVERY FOR MANUFACTURING AND DISTRIBUTION,BUT NOT RESEARCH AND DEVELOPMENT; REGULATION GOES INTO EFFECT JAN. 16, 1998
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers participating in treatment-use investigational device exemptions can recover costs only for manufacturing and distribution expenses, FDA says in its final rule on treatment IDEs, published in the Sept. 18 Federal Register.