Sec. 615. SENTINEL
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## SEC. 615 SENTINEL Section 519 (21 U.S.C. 360i) is amended by adding at the end the following: > > ### “(h) Inclusion of Devices in the Postmarket Risk Identification and Analysis System > > > #### “(1) In general > > > ##### “(A) Application to devices > > The Secretary shall amend the procedures established and maintained under clauses (i), (ii), (iii), and
(v)of section 505(k)(3)(C) in order to expand the postmarket risk identification and analysis system established under such section to include and apply to devices. > > > ##### “(B) Exception > > Subclause
(II)of clause
(i)of section 505(k)(3)(C) shall not apply to devices. > > > ##### “(C) Clarification > > With respect to devices, the private sector health-related electronic data provided under section 505(k)(3)(C)(i)(III)(bb) may include medical device utilization data, health insurance claims data, and procedure and device registries. > > > #### “(2) Data > > In expanding the system as described in paragraph (1)(A), the Secretary shall use relevant data with respect to devices cleared under section 510(k) or approved under section 515, including claims data, patient survey data, and any other data deemed appropriate by the Secretary. > > > #### “(3) Stakeholder input > > To help ensure effective implementation of the system as described in paragraph
(1)with respect to devices, the Secretary shall engage outside stakeholders in development of the system, and gather information from outside stakeholders regarding the content of an effective sentinel program, through a public hearing, advisory committee meeting, maintenance of a public docket, or other similar public measures. > > > #### “(4) Voluntary surveys > > Chapter 35 of title 44, United States Code, shall not apply to the collection of voluntary information from health care providers, such as voluntary surveys or questionnaires, initiated by the Secretary for purposes of postmarket risk identification, mitigation, and analysis for devices.” > .
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