TREATMENT-USE IDE COST-RECOVERY RESTRICTIONS WEIGHED BY FDA DUE TO COMMERCIALIZATION CONCERNS; AGENCY SEEKS COMMENTS ON SAFEGUARDS IN PROPOSED REG
This article was originally published in The Gray Sheet
Executive SummaryFDA's treatment-use investigational device exemption proposal may require additional cost recovery restrictions beyond those normally imposed on devices subject to IDEs in order to protect against commercialization of unapproved devices, the agency indicates in a Dec. 19 Federal Register notice announcing the proposed rule.
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