[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3847 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 3847

  To amend the Federal Food, Drug, and Cosmetic Act to ensure that a 
medical device is not marketed based on a determination that the device 
    is substantially equivalent to a predicate device that has been 
recalled, corrected, or removed from the market because of an intrinsic 
  flaw in technology or design that adversely affects safety, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 31, 2012

 Mr. Markey (for himself, Mr. Waxman, Ms. Schakowsky, and Ms. DeLauro) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to ensure that a 
medical device is not marketed based on a determination that the device 
    is substantially equivalent to a predicate device that has been 
recalled, corrected, or removed from the market because of an intrinsic 
  flaw in technology or design that adversely affects safety, 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 ``Safety Of Untested and New Devices 
Act of 2012'' or the ``SOUND Devices Act of 2012''.

SEC. 2. PREDICATE DEVICES THAT HAVE BEEN RECALLED, CORRECTED, OR 
              REMOVED FROM THE MARKET.

    (a) Submission of Information by Persons Seeking Substantial 
Equivalence Determination.--Section 513(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(i)) is amended--
            (1) by redesignating paragraph (3) as paragraph (5); and
            (2) by striking paragraph (2) and inserting the following:
    ``(2)(A) Any person seeking a determination of substantial 
equivalence under subsection (f) or section 520(l) for a device shall 
submit to the Secretary information (to the extent such information is 
readily available) on the market status of--
            ``(i) each predicate device; and
            ``(ii) each device in the full device lineage (as defined 
        in subparagraph (C)).
    ``(B) With respect to each device described in clause (i) or (ii) 
of subparagraph (A), the information required to be submitted under 
subparagraph (A) shall specify--
            ``(i) whether the device has been corrected or removed from 
        the market;
            ``(ii) if so, the basis for such correction or removal, 
        including whether such correction or removal was because of an 
        intrinsic flaw in technology or design that adversely affects 
        safety; and
            ``(iii) why the device for which a substantial equivalence 
        determination is sought does not share any such intrinsic flaw.
    ``(C) In this paragraph, the term `device in the full device 
lineage' means a device for which a substantial equivalence 
determination was made leading to a substantial equivalence 
determination for a predicate device referred to in subparagraph 
(A)(i).''.
    (b) Rejecting Claims of Substantial Equivalence.--Section 513(i) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)), as 
amended, is further amended by inserting after paragraph (2) the 
following:
    ``(3) The Secretary--
            ``(A) shall not find a device to be substantially 
        equivalent to a predicate device that has been--
                    ``(i) removed from the market at the initiative of 
                the Secretary; or
                    ``(ii) determined to be misbranded or adulterated 
                by judicial order;
            ``(B) may reject a claim that a device is substantially 
        equivalent to a predicate device if--
                    ``(i) the predicate device, or any device in a 
                series of one or more devices for which a substantial 
                equivalence determination was made leading to a 
                substantial equivalence determination for the predicate 
                device, has been corrected or removed from the market--
                            ``(I) at the initiative of the sponsor; or
                            ``(II) under any other circumstance not 
                        covered by subparagraph (A); and
                    ``(ii) the correction or removal is due, in whole 
                or in part, to an intrinsic flaw in technology or 
                design that adversely affects safety;
            ``(C) may reject a claim that a device is substantially 
        equivalent to a predicate device if--
                    ``(i) the Secretary is in the process of rescinding 
                the clearance granted under section 510(k), issuing or 
                amending an order under section 518(e) (relating to 
                recall authority), or taking any other regulatory 
                action because of an intrinsic flaw in technology or 
                design that adversely affects safety, with respect to--
                            ``(I) the predicate device; or
                            ``(II) any device in the full predicate 
                        device lineage (meaning any device for which a 
                        substantial equivalence determination was made 
                        leading to a substantial equivalence 
                        determination for the predicate device); or
                    ``(ii) the manufacturer or importer of a device 
                described in subclause (I) or (II) of clause (i) is in 
                the process of correcting or removing the device from 
                the market; and
            ``(D) may reject a claim that a device is substantially 
        equivalent to a predicate device if the predicate device has 
        been corrected or removed from the market and the manufacturer 
        or importer of the predicate failed to submit notice of such 
        correction or removal in accordance with section 519(g).''.
    (c) Database on Eligible Predicate Devices.--Section 513(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)), as amended, 
is further amended by inserting after paragraph (3) the following:
    ``(4)(A) The Secretary shall maintain an up-to-date database that 
can be used by the Secretary for purposes of determining whether 
devices are eligible under paragraph (3) for use as a predicate device.
    ``(B) The Secretary shall determine whether a device is eligible 
under paragraph (3) for use as a predicate device, and shall make 
appropriate updates to the database under this paragraph, whenever--
            ``(i) the Secretary issues, vacates, or amends an order for 
        a device under section 518(e) (relating to recall authority);
            ``(ii) the manufacturer or importer of a device reports a 
        correction or removal of a device under subsection (g) or (h) 
        of section 519; or
            ``(iii) the Secretary otherwise learns of a correction or 
        removal of a device (as such terms are used in subsections (g) 
        and (h) of section 519).
    ``(C) Upon making a determination required by subparagraph (B), the 
Secretary shall include in the database under this paragraph 
information, to the extent such information is available to the 
Secretary, about the reason for the order, correction, or removal.
    ``(D) The Secretary shall publish notice of each determination 
under subparagraph (B).''.
    (d) Reports of Corrections and Removals.--
            (1) In general.--Section 519 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end 
        the following:
    ``(h) Inclusion of Root Cause Analysis in Reports of Removals and 
Corrections.--
            ``(1) Requirement.--Whenever a manufacturer or importer of 
        a device is required to submit a report under subsection (g) on 
        a corrective action or removal of the device, and whenever a 
        manufacturer or importer would be so required but for 
        submitting a report under subsection (a) on a corrective action 
        or removal of the device, the manufacturer or importer shall 
        submit, as an addendum to the submitted report, the root cause 
        assessment of each device defect leading to the corrective 
        action or removal.
            ``(2) Timing.--An addendum required by paragraph (1) shall 
        be submitted to the Secretary promptly, and not later than 90 
        days after the corrective action or removal.''.
            (2) Reports for devices in same lineage as devices subject 
        to corrections and removals.--
                    (A) Authority to order reports.--Section 519 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i), 
                as amended, is further amended by adding at the end the 
                following:
    ``(i) Reports for Devices in Same Lineage as Devices Subject to 
Corrections and Removals.--
            ``(1) In general.--When a device is corrected or removed 
        from the market because of an intrinsic flaw in technology or 
        design that adversely affects safety--
                    ``(A) the Secretary may order the manufacturer or 
                importer of each device in the same lineage which 
                continues to be marketed to submit a report described 
                in paragraph (2); and
                    ``(B) not later than 30 days after receipt of such 
                an order, the manufacturer or importer of each such 
                device shall submit the report.
            ``(2) Report contents.--A report described in this 
        paragraph shall--
                    ``(A) state whether the device for which the report 
                is submitted shares any intrinsic flaw in technology or 
                design associated with the device which is corrected or 
                removed from the market; and
                    ``(B) if not, explain why the device for which the 
                report is submitted does not share any such intrinsic 
                flaw.
            ``(3) Definition.--In this subsection, the term `device in 
        the same lineage' refers to a device if--
                    ``(A) a substantial equivalence determination was 
                made for the device corrected or removed from the 
                market; and
                    ``(B) such determination leads to a substantial 
                equivalence determination for the device involved.''.
                    (B) Conforming amendment.--Section 303(f)(1)(B) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                333(f)(1)(B)) is amended by striking ``or 519(g)'' and 
                inserting ``, 519(g), or 519(h)''.
    (e) Review of Previously Cleared Life-Sustaining, Life-Supporting, 
or Implantable Devices.--
            (1) Review.--The Secretary shall conduct a review of all 
        covered devices to identify any such devices with respect to 
        which a predicate device, or any device in the full device 
        lineage, has been corrected or removed from the market pursuant 
        to a Class I or Class II recall.
            (2) Priority.--In conducting the review under paragraph 
        (1), the Secretary shall prioritize--
                    (A) the review of covered devices that pose the 
                highest risk to patients; and
                    (B) the identification of covered devices that 
                share with another device an intrinsic flaw in 
                technology or design that--
                            (i) adversely affects safety; and
                            (ii) led to the correction or removal from 
                        the market of the other device.
            (3) Report.--Not later than 3 years after the date of the 
        enactment of this Act, the Secretary shall submit a report to 
        the Congress on the progress made by the Secretary in 
        implementing this subsection.
            (4) Definitions.--In this subsection:
                    (A) The terms ``Class I'', ``Class II'', and 
                ``recall'' have the meanings given to such terms in 
                section 7.3 of title 21, Code of Federal Regulations 
                (or any successor regulations).
                    (B) The term ``covered device'' means a device (as 
                defined in section 201 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 321)) that--
                            (i) is cleared under section 510(k) of such 
                        Act (21 U.S.C. 360(k)) before the effective 
                        date of the amendments made by subsections (a) 
                        through (d);
                            (ii) is life-sustaining, life-supporting, 
                        or implantable; and
                            (iii) continues to be marketed.
                    (C) The term ``device in the full device lineage'' 
                means a device for which a substantial equivalence 
                determination was made leading to a substantial 
                equivalence determination for a predicate device 
                referred to in paragraph (1).
                    (D) The term ``Secretary'' means the Secretary of 
                Health and Human Services, acting through the 
                Commissioner of Food and Drugs.
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