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5,857 results found

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Skadden Arps Slate Meagher & Flom LLP | USA | 21 Apr 2021

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Recent settlements between the U.S. Department of Justice (DOJ) and a range of FDA-regulated drug and medical device manufacturers provide a snapshot…
Article

Hogan Lovells | USA | 20 Apr 2021

HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their…
Article

Bristows | European Union | 20 Apr 2021

Notified Bodies - An update

In previous articles we have highlighted the low number of Notified Bodies as one of the medical device industry’s most pressing concerns ahead of…
Article

Jingtian & Gongcheng | China | 9 Apr 2021

List of Clinical Testing in Medical Institutions

On March 18, 2021, the newly revised Regulations on Supervision and Administration of Medical Devices (《医疗器械监督管理条例》, “New Regulation”) has been…
Article

Simmons & Simmons LLP | Germany | 7 Apr 2021

Exceptional authorisations for rapid COVID-19 tests for laypeople

Besides vaccination, one of the most important measures to counter the COVID-19 pandemic is to test people for the virus and order them to quarantine…
Article

Morrison & Foerster LLP | European Union | 6 Apr 2021

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will…
Article

Morrison & Foerster LLP | European Union, USA | 24 Mar 2021

Software As A Medical Device In Europe - New Regulatory Regime About To Enter Into Force - (Part 5 of 6)

The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical…
Article

Duane Morris LLP | USA | 22 Mar 2021

510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned

On March 2, 2021, a New Jersey appellate court overturned two pelvic mesh jury verdicts totaling over $83 million dollars, holding that the trial…
Article

Jingtian & Gongcheng | China | 19 Mar 2021

管中窥豹读新《医疗器械监督管理条例》

2021年3月18日,新版《医疗器械监督管理条例》(“新版条例”)正式发布。新版条例将于今年6月1日起正式施行。相较于现行2017年版《医疗器械监督管理条例》…
Article

Hogan Lovells | USA | 18 Mar 2021

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the…
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