Publications

Hogan Lovells Publications

FDA issues new final guidance on Medical Device Reporting requirements

On 8 November 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Reporting for Manufacturers1, which represents FDA's...

Hogan Lovells Publications

DuPont's Upgraded Manufacturing Process Regarding Their Tyvek® Material and Impact on Medical Device Manufacturers

In an announcement issued by the Food and Drug Administration on October 2, 2015, the agency has determined that the performance of the new Tyvek® material is functionally equivalent to...

Hogan Lovells Publications

Final FDA Guidance Clarifies Distinction Between Medical Device Recalls and Enhancements

On 15 October 2014, the Food and Drug Administration issued its final guidance clarifying the difference between medical device recalls and device enhancements. This document replaces the...

Hogan Lovells Publications

President signs new law reauthorizing Medical Device User Fee Act and enacting broad-ranging FDA Safety and Innovation Act

On July 9, 2012, President Obama signed into law the FDA Safety and Innovation Act (FDASIA). The new law implements nearly three dozen provisions relevant to the medical device industry, in ...

Hogan Lovells Publications

FDA Releases Highly-Anticipated Working Group Reports on 510(k) Program, New Science

On Wednesday, 4 August 2010, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released the highly-anticipated preliminary reports of two...

Published Works

The Quality System Regulation

Published Works

The Framework for Regulation of Medical Devices

Published Works

Medical Device Exports and Imports

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