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02068aam a2200313 i 4500 001 A925ACBC323411EC8B1165C359ECA4DB 003 SILO 005 20211021010114 008 210907t20212021iluk b 001 0 eng c 020 $a 1641059702 020 $a 9781641059701 035 $a (OCoLC)1267411885 040 $a UPM $b eng $e rda $c UPM $d WLL $d OCLCO $d CLU $d SILO 042 $a pcc 043 $a n-us--- 050 4 $a KF3827.M4 $b B74 2021 245 00 $a Bringing medical devices to market / $c Charlene Cho, editor. 264 1 $a Chicago, Illinois: $b American Bar Association Health Law Section, $c [2021] 300 $a xxx, 389 pages : $b forms ; $c 23 cm 504 $a Includes bibliographical references and index. 505 0 $a FDA premarket requirements / Vernessa T. Pollard and Anisa Mohanty -- FDA regulation of digital health care products / Jeffrey N. Gibbs and Allyson B. Mullen -- Data, clinical trials, and good clinical practices / Gerard Prud'homme, Kristen Zielinski Duggan, Megana Sankaran -- Intellectual property protections for medical devices / Ed Buthusiem, Jeffrey Klenk, and Eric Carlson -- Business arrangements and contractual agreements / David Hatch and Robert Miller -- Postmarket requirements / Paul Gadiock and Jamie Ravitz -- Compliance and enforcement / Paul Gadiock and Jamie Ravitz -- Import/exports / Allison Fulton -- Fraud and abuse laws / Charlene Cho and Jennifer Michael -- Coverage, coding, and reimbursement for medical devices / Beth Halpern, with Mahmud Brifkani, Boyd Jackson, Soraya Keskey, and Maria Malas -- AI--products liability / Terrence Dee. 650 0 $a Medical instruments and apparatus $x Law and legislation $z United States. 650 0 $a Medical technology $x Law and legislation $z United States. 650 0 $a New products $x Law and legislation $z United States. 710 2 $a American Bar Association. $b Health Law Section, $e sponsoring body. 700 1 $a Cho, Charlene, $e editor. 941 $a 1 952 $l OVUX522 $d 20220526014935.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=A925ACBC323411EC8B1165C359ECA4DBInitiate Another SILO Locator Search