标签档案:Device Preemption

FDA关于管制最不发达国家的建议对实验室提出了法律责任问题。

八月回来we wrote about the FDA's controversial plan to release 德赢真人视讯draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) —  diagnostic tests developed by and used within individual laboratories across the country.  As it stands now,LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical … 继续阅读

Fifth Circuit Holds That Product Development Protocol Has Same Preemptive Effect As Premarket Approval

关于先发制人原则在医疗器械产品责任案件中的适用性的讨论通常集中在两种器械上:(1)根据FDA上市前批准程序批准的三类医疗器械,以及(2)通过不太严格的510(k)过程清除的设备。A recent case reminds us of a different pathway to approval,which carries … 继续阅读

印第安纳州上诉法院没有发现PMA对索赔的优先权,前提是制造商代表在手术期间提供的据称是疏忽的建议。

虽然大多数涉及经上市前批准的第三类设备的产品责任索赔都是先发制人的(见上一篇文章)。the recent case of Medtronic,公司。v.诉Malander demonstrates that there are some circumstances in which preemption may not apply.  Specifically,the Malander court concluded that preemption does not apply where a representative of the manufacturer … 继续阅读

Supreme Court Seeks Solicitor General's Views on Cert Petition in Closely-Watched Preemption Case

一月,我们写了关于第九巡回法院在斯坦格尔诉案中有争议的裁决。Medtronic,认为原告的产品责任主张,which were premised on Medtronic's alleged failure to report post-approval information regarding its pain pump to the FDA,没有先发制人。对于案件的详细讨论,please refer to our previous post.  … 继续阅读

生物材料准入保障是医疗器械零部件供应商的防御性工具。

We recently came across an interesting medical device case from the Western District of Kentucky,Sadler v.高级仿生学,有限责任公司,2013 WL 1636374 (W.D.Ky.Apr.16,2013)involving the Biomaterials Access Assurance Act of 1998 ("BAAA"),21 U.S.C.§1601-1606。正如萨德勒提醒我们的,the BAAA can be a useful tool for suppliers of medical … 继续阅读
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