Publications

Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

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

FDA finalizes guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies

On September 12, 2017, the U.S. Food and Drug Administration (FDA) released the final guidance that outlines the agency’s expectations and recommendations for the evaluation and...

Hogan Lovells Publications

FDA’s software Pre-Cert program: More details revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert)...

Hogan Lovells Publications

FDA unveils software pre-certification pilot program to foster digital health innovation

Following promises in June for a new regulatory paradigm to address regulation of medical software, FDA released a Digital Health Innovation Action Plan on July 27, 2017, including a pilot...

Hogan Lovells Publications

FDA Cleared First DTC Genetic Tests for Health Risks

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the...

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...

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