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    HR3200 Page 1193

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    gordonfurr
    This document proposes amendments to establish a national medical device registry to facilitate analysis of postmarket safety and outcomes data on class III and implantable class II medical devices. The Secretary of Health and Human Services would develop the registry in consultation with other agencies to determine how to include device identification data, validate methods for analyzing patient data from multiple sources, and integrate the registry's activities with other postmarket drug and device surveillance programs. The goal is to provide public access to the data and analysis collected through the registry.

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    HR3200 Page 1193

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    gordonfurr
    22 views2 pages
    This document proposes amendments to establish a national medical device registry to facilitate analysis of postmarket safety and outcomes data on class III and implantable class II medical devices. The Secretary of Health and Human Services would develop the registry in consultation with other agencies to determine how to include device identification data, validate methods for analyzing patient data from multiple sources, and integrate the registry's activities with other postmarket drug and device surveillance programs. The goal is to provide public access to the data and analysis collected through the registry.

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    REFERENCES IMPLANTABLE DEVICES

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    HR3200 PAGE 1193

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    This document proposes amendments to establish a national medical device registry to facilitate analysis of postmarket safety and outcomes data on class III and implantable class II medical devices. The Secretary of Health and Human Services would develop the registry in consultation with other agencies to determine how to include device identification data, validate methods for analyzing patient data from multiple sources, and integrate the registry's activities with other postmarket drug and device surveillance programs. The goal is to provide public access to the data and analysis collected through the registry.

    Copyright:

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    22 views2 pages

    HR3200 Page 1193

    Uploaded by

    gordonfurr
    This document proposes amendments to establish a national medical device registry to facilitate analysis of postmarket safety and outcomes data on class III and implantable class II medical devices. The Secretary of Health and Human Services would develop the registry in consultation with other agencies to determine how to include device identification data, validate methods for analyzing patient data from multiple sources, and integrate the registry's activities with other postmarket drug and device surveillance programs. The goal is to provide public access to the data and analysis collected through the registry.

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    of 2

    1193 1 2 3 4 5 6 7 8 9 (1) IN

    GENERAL.Section

    519 of the Federal

    Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended (A) by redesignating subsection (g) as subsection (h); and (B) by inserting after subsection (f) the following: National Medical Device Registry (g)(1) The Secretary shall establish a national med-

    10 ical device registry (in this subsection referred to as the reg11 istry) to facilitate analysis of postmarket safety and out12 comes data on each device that 13 14 15 16 17 18 (A) is or has been used in or on a patient; and (B) is (i) a class III device; or (ii) a class II device that is implantable, life-supporting, or life-sustaining. (2) In developing the registry, the Secretary shall, in

    19 consultation with the Commissioner of Food and Drugs, the 20 Administrator of the Centers for Medicare & Medicaid Serv21 ices, the head of the Office of the National Coordinator for 22 Health Information Technology, and the Secretary of Vet23 erans Affairs, determine the best methods for
    bajohnson on DSK2BSOYB1PROD with BILLS

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    (A) including in the registry, in a manner consistent with subsection (f), appropriate information to

    HR 3200 RH
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    1194 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
    bajohnson on DSK2BSOYB1PROD with BILLS

    identify each device described in paragraph (1) by type, model, and serial number or other unique identifier; (B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of (i) data provided to the Secretary under other provisions of this chapter; and (ii) information from public and private sources identified under paragraph (3); (C) integrating the activities described in this subsection with (i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification); (ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data); and (iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; and (D) providing public access to the data and analysis collected or developed through the registry in

    24 25

    HR 3200 RH
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