<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/" style="-uslm-lc:I80" id="id5f5fde18-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603"><num value="1603">§ 1603.</num><heading> General requirements; applicability; preemption</heading><subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="id5f5fde19-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/a"><num value="a" class="bold">(a)</num><heading class="bold"> General requirements</heading><paragraph style="-uslm-lc:I79" class="indent3 firstIndent-2" id="id5f5fde1a-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/a/1"><num value="1" class="bold">(1)</num><heading class="bold"> In general</heading><chapeau>In any civil action covered by this chapter, a biomaterials supplier may—</chapeau><subparagraph style="-uslm-lc:I13" class="indent2" id="id5f5fde1b-ceff-11e7-ac08-9eab3197d358" 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 style="-uslm-lc:I13" class="indent2" id="id5f60052c-ceff-11e7-ac08-9eab3197d358" 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 style="-uslm-lc:I79" class="indent3 firstIndent-2" id="id5f60052d-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/a/2"><num value="2" class="bold">(2)</num><heading class="bold"> 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>
</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="id5f60052e-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/b"><num value="b" class="bold">(b)</num><heading class="bold"> Applicability</heading><paragraph style="-uslm-lc:I79" class="indent3 firstIndent-2" id="id5f60052f-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/b/1"><num value="1" class="bold">(1)</num><heading class="bold"> 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 style="-uslm-lc:I79" class="indent3 firstIndent-2" id="id5f600530-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/b/2"><num value="2" class="bold">(2)</num><heading class="bold"> Exclusion</heading><chapeau>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 style="-uslm-lc:I13" class="indent2" id="id5f600531-ceff-11e7-ac08-9eab3197d358" 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 style="-uslm-lc:I13" class="indent2" id="id5f600532-ceff-11e7-ac08-9eab3197d358" 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 style="-uslm-lc:I19" class="indent2 firstIndent-2" id="id5f600533-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/c"><num value="c" class="bold">(c)</num><heading class="bold"> Scope of preemption</heading><paragraph style="-uslm-lc:I79" class="indent3 firstIndent-2" id="id5f600534-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/c/1"><num value="1" class="bold">(1)</num><heading class="bold"> 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 style="-uslm-lc:I79" class="indent3 firstIndent-2" id="id5f600535-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/c/2"><num value="2" class="bold">(2)</num><heading class="bold"> 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 style="-uslm-lc:I19" class="indent2 firstIndent-2" id="id5f600536-ceff-11e7-ac08-9eab3197d358" identifier="/us/usc/t21/s1603/d"><num value="d" class="bold">(d)</num><heading class="bold"> Statutory construction</heading><chapeau>Nothing in this chapter may be construed—</chapeau><paragraph style="-uslm-lc:I12" class="indent1" id="id5f600537-ceff-11e7-ac08-9eab3197d358" 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 style="-uslm-lc:I12" class="indent1" id="id5f600538-ceff-11e7-ac08-9eab3197d358" 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="id5f600539-ceff-11e7-ac08-9eab3197d358">(<ref href="/us/pl/105/230">Pub. L. 105–230</ref>, § 4, <date date="1998-08-13">Aug. 13, 1998</date>, <ref href="/us/stat/112/1523">112 Stat. 1523</ref>.)</sourceCredit>
<notes type="uscNote" id="id5f60053a-ceff-11e7-ac08-9eab3197d358">
<note style="-uslm-lc:I74" topic="effectiveDate" id="id5f60053b-ceff-11e7-ac08-9eab3197d358"><heading class="centered smallCaps">Effective Date</heading><p style="-uslm-lc:I21" class="indent0">Section applicable to all civil actions covered under this chapter commenced on or after <date date="1998-08-13">Aug. 13, 1998</date>, including any in which the harm or harmful conduct occurred before such date, see <ref href="/us/pl/105/230/s8">section 8 of Pub. L. 105–230</ref>, set out as a note under <ref href="/us/usc/t21/s1601">section 1601 of this title</ref>.</p>
</note>
</notes>
</section>