type: contracts

jurisdiction: EU

text:
 4.8.2016
 SK
 Úradný vestník Európskej únie
 L 211/74
 ROZHODNUTIE SPOLOČNÉHO VÝBORU EHP
 č. 116/2015
 z 30. apríla 2015,
 ktorým sa mení príloha XIII (Doprava) a príloha XIX (Ochrana spotrebiteľa) k Dohode o EHP [2016/1299]
 SPOLOČNÝ VÝBOR EHP,
 so zreteľom na Dohodu o Európskom hospodárskom priestore (ďalej len „Dohoda o EHP“), a najmä na jej článok 98,
 keďže:
 (1)
 Nariadenie Európskeho parlamentu a Rady (EÚ) č. 1177/2010 z 24. novembra 2010 o právach cestujúcich v námornej a vnútrozemskej vodnej doprave, ktorým sa mení a dopĺňa nariadenie (ES) č. 2006/2004 (1), sa má začleniť do Dohody o EHP.
 (2)
 Prílohy XIII a XIX k Dohode o EHP by sa preto mali zodpovedajúcim spôsobom zmeniť,
 PRIJAL TOTO ROZHODNUTIE:
 Článok 1
 Za bod 56x [nariadenie Európskeho parlamentu a Rady (ES) č. 392/2009] prílohy XIII k Dohode o EHP sa vkladá tento bod:
 „56y.
 32010 R 1177: nariadenie Európskeho parlamentu a Rady (EÚ) č. 1177/2010 z 24. novembra 2010 o právach cestujúcich v námornej a vnútrozemskej vodnej doprave, ktorým sa mení a dopĺňa nariadenie (ES) č. 2006/2004 (Ú. v. EÚ L 334, 17.12.2010, s. 1).“
 Článok 2
 V bode 7f [nariadenie Európskeho parlamentu a Rady (ES) č. 2006/2004] prílohy XIX k Dohode o EHP sa dopĺňa táto zarážka:
 „—
 32010 R 1177: nariadenie Európskeho parlamentu a Rady (EÚ) č. 1177/2010 z 24. novembra 2010 (Ú. v. EÚ L 334, 17.12.2010, s. 1).“
 Článok 3
 Znenie nariadenia (EÚ) č. 1177/2010 v islandskom a nórskom jazyku, ktoré sa uverejní v dodatku EHP k Úradnému vestníku Európskej únie, je autentické.
 Článok 4
 Toto rozhodnutie nadobúda účinnosť 1. mája 2015 pod podmienkou, že boli doručené všetky oznámenia podľa článku 103 ods. 1 Dohody o EHP (*).
 Článok 5
 Toto rozhodnutie sa uverejní v oddiele EHP Úradného vestníka Európskej únie a v dodatku EHP k Úradnému vestníku Európskej únie.
 V Bruseli 30. apríla 2015
 Za Spoločný výbor EHP
 predseda
 Gianluca GRIPPA
 (1) Ú. v. EÚ L 334, 17.12.2010, s. 1.
 (*) Ústavné požiadavky boli oznámené.


type: legislation

jurisdiction: US

text:
 I
 112th CONGRESS
 2d Session
 H. R. 3847
 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.
 1.Short titleThis Act may be cited as the
 Safety Of Untested and New Devices Act of
 2012 or the SOUND Devices Act of
 2012.
 2.Predicate devices
 that have been recalled, corrected, or removed from the market
 (a)Submission of
 information by persons seeking substantial equivalence
 determinationSection 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 equivalenceSection 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 devicesSection 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
 generalSection 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)RequirementWhenever
 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)TimingAn
 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 reportsSection 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
 generalWhen 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
 contentsA 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)DefinitionIn 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
 amendmentSection 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)ReviewThe 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)PriorityIn 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)ReportNot
 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)DefinitionsIn 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.