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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5341 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 5341

To improve postmarket risk identification and analysis with respect to 
                    devices, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 7, 2012

  Mrs. Capps introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
To improve postmarket risk identification and analysis with respect to 
                    devices, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Sentinel Assurance for Effective 
Devices Act of 2012''.

SEC. 2. INCLUSION OF DEVICES IN POSTMARKET RISK IDENTIFICATION AND 
              ANALYSIS SYSTEM; UNIQUE DEVICE IDENTIFICATION SYSTEM.

    (a) Inclusion of Devices in Postmarket Risk Identification and 
Analysis System.--Section 522 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360l) is amended by adding at the end the following:
    ``(d) Inclusion of Devices in the Postmarket Risk Identification 
and Analysis System.--
            ``(1) In general.--Except as provided in paragraph (2), the 
        Secretary shall amend the procedures established and maintained 
        under 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.
            ``(2) Exceptions.--In carrying out this subsection:
                    ``(A) The Secretary shall not apply the procedures 
                of section 505(k)(3)(C)(i)(II) to devices.
                    ``(B) Section 505(k)(3)(C)(i)(III)(bb) is deemed to 
                refer to private sector health-related electronic data 
                (such as medical device utilization data, health 
                insurance claims data, and procedure and device 
                registries).
                    ``(C) Section 505(k)(3)(C)(iv)(II) is deemed to 
                refer to the Data Extraction and Longitudinal Time 
                Analysis system instead of the Vaccine Safety Datalink.
            ``(3) Priority.--In carrying out this subsection, the 
        Secretary shall give priority to postmarket risk identification 
        and analysis with respect to class II and class III devices.
            ``(4) Stakeholder input.--To help ensure effective 
        implementation of the system 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.
            ``(5) Data.--In carrying out this subsection, the Secretary 
        shall use data with respect to devices cleared under section 
        510(k) or approved under section 515, which may include claims 
        data, patient survey data, standardized analytic files that 
        allow for the pooling and analysis of data from disparate data 
        environments, and any other data deemed appropriate by the 
        Secretary.
            ``(6) 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 for devices.''.
    (b) Unique Device Identification System.--Section 519(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) is amended--
            (1) by striking ``The Secretary shall promulgate'' and 
        inserting ``Not later than December 31, 2012, the Secretary 
        shall issue final''; and
            (2) by adding at the end the following: ``The Secretary 
        shall implement the unique device identification system under 
        this subsection for class III devices not later than 1 year 
        after the date on which the final regulations are issued, for 
        implantable, life-sustaining, and life-supporting devices not 
        later than 3 years after such date, and for all other devices 
        not later than 5 years after such date.''.
                                 <all>
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