CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.

SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS. Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: “(8)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a ‘clinical hold’) if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing. “(B) For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that— “(i) the device involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved; or “(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish. “(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.” .