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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law Blog

JANUARY 5, 2023

In mid-November, FDA collaborated with the MITRE Corporation to publish an update to the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. By Philip Won & Lisa M.

Electronics

Electronics Manufacturing Provider IT

Primary Care Digest

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

Are You Recall Ready? FDA Expects You to Be

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