Erkang Ai, Ph.D. on Medical Devices

Federal court vacates FDA Laboratory Developed Test rule

Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is...more

4/2/2025 / Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Regulatory Authority , Regulatory Requirements

FDA transition plan for COVID-19 medical devices requests new submissions to agency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more

1/11/2022 / Coronavirus/COVID-19 , Draft Guidance , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Public Comment , Public Health Emergency

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 approval) devices to class II (subject...more

6/19/2018 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Software , Pharmaceutical Industry , Proposed Rules , Regulatory Oversight , Regulatory Requirements

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. Unlike most IVDs that typically detect...more

4/23/2018 / Clinical Laboratory Testing , Databases , Final Rules , Food and Drug Administration (FDA) , Genetic Testing , Medical Devices , Pharmaceutical Industry , Regulatory Oversight

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 reporting of age-, race-, and...more

10/5/2017 / Clinical Trials , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Reporting Requirements

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) program, the Agency held an August 1, 2017,...more

8/10/2017 / 21st Century Cures Initiative , Digital Health , FDA Approval , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Medical Software , Regulatory Standards

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 first FDA authorization for a...more

4/18/2017 / 23andMe , Clinical Laboratories , Food and Drug Administration (FDA) , Genetic Markers , Genetic Testing , Human Genes , Laboratory Developed Tests , Life Sciences , Marketing , Medical Devices , Pharmaceutical Industry

Erkang Ai, Ph.D.

Hogan Lovells

Popular Topics by This Author

Latest Posts › Medical Devices