Hamilton Barber

Maynard Nexsen

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Latest Posts › Medical Devices

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FDA Collaborates with MITRE to update Medical Device Cybersecurity Playbook

On November 14, 2022, under contract with the United States Food and Drug Administration (FDA), the MITRE Corporation (MITRE), an organization that administers the National Cybersecurity Center of Excellence, a federally...more

12/7/2022 / Cyber Attacks , Cyber Threats , Cybersecurity , Food and Drug Administration (FDA) , Medical Devices , Popular , Ransomware

FDA Final Rules Allows Over The Counter Hearing Aids

On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule (the “Rule”) that enables adult consumers (18 years of age or older) with perceived mild to moderate hearing impairment to purchase certain...more

9/22/2022 / Final Rules , Food and Drug Administration (FDA) , Medical Devices , Over The Counter Drugs (OTC)

FDA Revises its Enforcement Policy for Respirators During the COVID-19 Public Health Emergency

Over the past several months, the United States Food and Drug Administration (FDA) has issued several guidance documents and guidelines to regulate the importation and distribution of respirators for medical purposes during...more

6/4/2020 / Coronavirus/COVID-19 , Enforcement Guidance , Food and Drug Administration (FDA) , Medical Devices , Public Health

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