{"identifier":"/us/usc/t21/s360k","title_num":"21","num":"§ 360k.","heading":"State and local requirements respecting devices","status":null,"guid":"id771d3707-bf32-11e3-bb6c-994f3311904d","source_credit":"(June 25, 1938, ch. 675, § 521, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 574.)","seq_in_title":163,"parent_identifier":"/us/usc/t21/ch9/schV/ptA","ancestors":[{"identifier":"/us/usc/t21","level":"title","num":"Title 21—","heading":"FOOD AND DRUGS","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9","level":"chapter","num":"CHAPTER 9—","heading":"FEDERAL FOOD, DRUG, AND COSMETIC ACT","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9/schV","level":"subchapter","num":"SUBCHAPTER V—","heading":"DRUGS AND DEVICES","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9/schV/ptA","level":"part","num":"Part A—","heading":"Drugs and Devices","status":null,"is_section":false}],"xml":"<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=\"id6ea36b26-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k\"><num value=\"360k\">§ 360k.</num><heading> State and local requirements respecting devices</heading><subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id6ea36b27-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/a\"><num value=\"a\" class=\"bold\">(a)</num><heading class=\"bold\"> General rule</heading><chapeau>Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—</chapeau><paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id6ea36b28-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/a/1\"><num value=\"1\">(1)</num><content> which is different from, or in addition to, any requirement applicable under this chapter to the device, and</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id6ea36b29-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/a/2\"><num value=\"2\">(2)</num><content> which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.</content>\n</paragraph>\n</subsection>\n<subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id6ea36b2a-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/b\"><num value=\"b\" class=\"bold\">(b)</num><heading class=\"bold\"> Exempt requirements</heading><chapeau>Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—</chapeau><paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id6ea36b2b-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/b/1\"><num value=\"1\">(1)</num><content> the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id6ea36b2c-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/b/2\"><num value=\"2\">(2)</num><chapeau> the requirement—</chapeau><subparagraph style=\"-uslm-lc:I13\" class=\"indent2\" id=\"id6ea36b2d-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/b/2/A\"><num value=\"A\">(A)</num><content> is required by compelling local conditions, and</content>\n</subparagraph>\n<subparagraph style=\"-uslm-lc:I13\" class=\"indent2\" id=\"id6ea36b2e-6123-11e3-9d46-8388bf8dcc60\" identifier=\"/us/usc/t21/s360k/b/2/B\"><num value=\"B\">(B)</num><content> compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.</content>\n</subparagraph>\n</paragraph>\n</subsection>\n<sourceCredit id=\"id6ea36b2f-6123-11e3-9d46-8388bf8dcc60\">(<ref href=\"/us/act/1938-06-25/ch675/s521\">June 25, 1938, ch. 675, § 521</ref>, as added <ref href=\"/us/pl/94/295/s2\">Pub. L. 94–295, § 2</ref>, <date date=\"1976-05-28\">May 28, 1976</date>, <ref href=\"/us/stat/90/574\">90 Stat. 574</ref>.)</sourceCredit>\n</section>","provision":null,"duplicates":[],"release":{"label":"113-88","currency_date":"2014-03-21","congress":113,"law_num":88,"excluded_laws":[],"update_num":null,"seq":14,"is_partial":false,"caveat":null,"titles_affected":["07","12","15","16","18","19","20","21","22","25","26","31","33","40","42","43","44","48"],"ingested_titles":[]},"served_from":{"label":"113-88","currency_date":"2014-03-21","congress":113,"law_num":88,"excluded_laws":[],"update_num":null,"seq":14,"is_partial":false,"caveat":null,"titles_affected":["07","12","15","16","18","19","20","21","22","25","26","31","33","40","42","43","44","48"],"ingested_titles":[]},"content_first_seen":{"label":"113-56","currency_date":"2013-12-02","congress":113,"law_num":56,"excluded_laws":[],"update_num":null,"seq":9,"is_partial":false,"caveat":null,"titles_affected":["21","22","42","49"],"ingested_titles":[]},"is_exact":true,"note":null}