Publications

Hogan Lovells Publications

FDA finalizes guidances for NGS-based tests

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests....

Hogan Lovells Publications

Clarifying digital health and software regulation: FDA releases three new guidance documents

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and...

Hogan Lovells Publications

FDA Finalizes Guidances for Blood Glucose Meters

On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued two final guidance documents describing studies and criteria that FDA recommends when submitting premarket...

Hogan Lovells Publications

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

On November 17, 2015, leaders from both the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) testified before the U.S. House of Representatives...

Hogan Lovells Publications

FDA Holds Workshop on Proposed Regulatory Framework for Laboratory Developed Tests

In early January, the FDA held a two-day meeting on the Agency’s proposed regulatory framework for Laboratory Developed Tests (LDTs). The meeting follows an announcement in mid-2014...

Hogan Lovells Publications

FDA Notifies Congress of the Proposed Regulatory Oversight of Laboratory Developed Tests

On July 31, 2014, the U.S. Food and Drug Administration (FDA or the Agency) announced plans to formally regulate laboratory developed tests (LDTs). The announcement came in the form of...

Hogan Lovells Publications

FDA Issues Final Guidance Regarding In Vitro Companion Diagnostic Devices

The Food and Drug Administration (FDA or the agency) announced on July 31, 2014, the publication of a final guidance on in vitro companion diagnostic devices. This guidance finalizes a...

Hogan Lovells Publications

FDA issues draft guidance regarding in vitro companion diagnostic devices, an area of device regulation marked by ambiguity

The Food and Drug Administration (FDA or "the Agency") announced on 14 July the publication of an anticipated draft guidance on in vitro companion diagnostic devices. The draft guidance...

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