Sentinel Assurance for Effective Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to: (1) amend the new drug approval application procedures to make the postmarket risk identification and analysis system applicable, with certain exceptions, to devices; (2) give priority to class II and class III devices; and (3) engage outside stakeholders in development of the system and gather information from them regarding the content of an effective sentinel program through measures involving the public.
Exempts the collection of voluntary information from health care providers for purposes of postmarket risk identification for devices from application of provisions for the coordination of federal information policy.
Requires the Secretary to issue final regulations concerning a unique device identification system no later than December 31, 2012, and to implement such system for class III devices no later than one year after the date of issuance of final regulations; for implantable, life-sustaining, and life-supporting devices no later than three years after such date; and for all other devices no later than five years after such date.
[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.''.
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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