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Medical Devices › Foreign Manufacturers

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Kramer Levin Naftalis & Frankel LLP

Advertising Litigation Report: Vol. 2, No. 2 - Lanham Act False Advertising

Kramer Levin Naftalis & Frankel LLP on

Summary Judgment Affirmed for Defendant in Lanham Act Challenge to Statements Concerning Popularity of Advertiser’s Product, Scarcity of Challenger’s Product: Verisign, Inc. v. XYZ.COM LLC, 848 F.3d 292 (4th Cir. 2017)...more

Foley Hoag LLP

Product Liability Update - July 2015

Foley Hoag LLP on

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Sheppard Mullin Richter & Hampton LLP

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

Sheppard Mullin Richter & Hampton LLP on

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

King & Spalding

2013 Year in Review: CDRH Promotion and Marketing Enforcement Letters

King & Spalding on

In 2013, FDA’s Center for Devices and Radiological Health (CDRH) made publicly available on its website a total of 22 promotion and marketing-related enforcement letters to device manufacturers. Of the 22 enforcement letters,...more

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