<section xmlns="http://xml.house.gov/schemas/uslm/1.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dcterms="http://purl.org/dc/terms/" id="id1e25c06f-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603"><num value="1603">§ 1603.</num><heading> General requirements; applicability; preemption</heading><subsection class="indent0" id="id1e25c070-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/a"><num value="a">(a)</num><heading> General requirements</heading><paragraph class="indent1" id="id1e25e781-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/a/1"><num value="1">(1)</num><heading> In general</heading>
<chapeau style="-uslm-lc:I12" class="blockIndent1">In any civil action covered by this chapter, a biomaterials supplier may—</chapeau><subparagraph class="indent2" id="id1e25e782-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/a/1/A"><num value="A">(A)</num><content> raise any exclusion from liability set forth in <ref href="/us/usc/t21/s1604">section 1604 of this title</ref>; and</content>
</subparagraph>
<subparagraph class="indent2" id="id1e25e783-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/a/1/B"><num value="B">(B)</num><content> make a motion for dismissal or for summary judgment as set forth in <ref href="/us/usc/t21/s1605">section 1605 of this title</ref>.</content>
</subparagraph>
</paragraph>
<paragraph class="indent1" id="id1e25e784-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/a/2"><num value="2">(2)</num><heading> Procedures</heading><content><p style="-uslm-lc:I12" class="indent1">Notwithstanding any other provision of law, a Federal or State court in which an action covered by this chapter is pending shall, in connection with a motion under section 1605 or 1606 of this title, use the procedures set forth in this chapter.</p>
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</paragraph>
</subsection>
<subsection class="indent0" id="id1e25e785-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/b"><num value="b">(b)</num><heading> Applicability</heading><paragraph class="indent1" id="id1e25e786-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/b/1"><num value="1">(1)</num><heading> In general</heading><content><p style="-uslm-lc:I12" class="indent1">Except as provided in paragraph (2), this chapter applies to any civil action brought by a claimant, whether in a Federal or State court, on the basis of any legal theory, for harm allegedly caused, directly or indirectly, by an implant.</p>
</content>
</paragraph>
<paragraph class="indent1" id="id1e25e787-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/b/2"><num value="2">(2)</num><heading> Exclusion</heading>
<chapeau style="-uslm-lc:I12" class="blockIndent1">A civil action brought by a purchaser of a medical device, purchased for use in providing professional health care services, for loss or damage to an implant or for commercial loss to the purchaser—</chapeau><subparagraph class="indent2" id="id1e260e98-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/b/2/A"><num value="A">(A)</num><content> shall not be considered an action that is subject to this chapter; and</content>
</subparagraph>
<subparagraph class="indent2" id="id1e260e99-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/b/2/B"><num value="B">(B)</num><content> shall be governed by applicable commercial or contract law.</content>
</subparagraph>
</paragraph>
</subsection>
<subsection class="indent0" id="id1e260e9a-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/c"><num value="c">(c)</num><heading> Scope of preemption</heading><paragraph class="indent1" id="id1e260e9b-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/c/1"><num value="1">(1)</num><heading> In general</heading><content><p style="-uslm-lc:I12" class="indent1">This chapter supersedes any State law regarding recovery for harm caused by an implant and any rule of procedure applicable to a civil action to recover damages for such harm only to the extent that this chapter establishes a rule of law applicable to the recovery of such damages.</p>
</content>
</paragraph>
<paragraph class="indent1" id="id1e260e9c-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/c/2"><num value="2">(2)</num><heading> Applicability of other laws</heading><content><p style="-uslm-lc:I12" class="indent1">Any issue that arises under this chapter and that is not governed by a rule of law applicable to the recovery of damages described in paragraph (1) shall be governed by applicable Federal or State law.</p>
</content>
</paragraph>
</subsection>
<subsection class="indent0" id="id1e260e9d-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/d"><num value="d">(d)</num><heading> Statutory construction</heading>
<chapeau style="-uslm-lc:I11" class="blockIndent0">Nothing in this chapter may be construed—</chapeau><paragraph class="indent1" id="id1e260e9e-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/d/1"><num value="1">(1)</num><content> to affect any defense available to a defendant under any other provisions of Federal or State law in an action alleging harm caused by an implant; or</content>
</paragraph>
<paragraph class="indent1" id="id1e2635af-f63b-11e2-8470-abc29ba29c4d" identifier="/us/usc/t21/s1603/d/2"><num value="2">(2)</num><content> to create a cause of action or Federal court jurisdiction pursuant to section 1331 or 1337 of title 28 that otherwise would not exist under applicable Federal or State law.</content>
</paragraph>
</subsection>
<sourceCredit id="id1e2635b0-f63b-11e2-8470-abc29ba29c4d">
(<ref href="/us/pl/105/230/s4">Pub. L. 105–230, § 4</ref>, <date date="1998-08-13">Aug. 13, 1998</date>, <ref href="/us/stat/112/1523">112 Stat. 1523</ref>.)</sourceCredit>
</section>