Publications

Hogan Lovells Publications

CDRH's Voluntary Malfunction Summary Reporting Program

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part...

Hogan Lovells Publications

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of...

Hogan Lovells Publications

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

Traditionally, the FDA’s collaboration with foreign authorities has meant a fairly predictable rate of US FDA inspections for foreign medical device manufacturers selling their...

Hogan Lovells Publications

FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement Decisions

On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product...

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...

Published Works

Medical Device Development: Regulation and Law

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