Lina Kontos on Draft Guidance

FDA finalizes advice on cybersecurity info to include in device submissions

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more

10/4/2023 / Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Popular

FDA Breakthrough Devices Program guidance targets health inequality

The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care,” which proposes updates to the...more

11/15/2022 / Comment Period , Disparate Impact , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more

1/12/2022 / Coronavirus/COVID-19 , Draft Guidance , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Medical Devices , Pharmaceutical Industry , Vaccinations

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On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more

1/11/2022 / Coronavirus/COVID-19 , Draft Guidance , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices ,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

Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS...more

10/3/2019 / 21st Century Cures Act , Clinical Evaluations , Draft Guidance , Food and Drug Administration (FDA) , Medical Software , Mobile Health Apps , Mobile Medical Applications , Pharmaceutical Industry

New draft guidance on MR compatibility for medical devices

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

8/13/2019 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Regulatory Agenda , Regulatory Oversight , Rulemaking Process

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more

2/11/2019 / 21st Century Cures Act , Combination Products , Comment Period , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Premarket Approval Applications , Regulatory Oversight , Regulatory Requirements

Lina Kontos

Hogan Lovells

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