Joshua Freemire

Joshua Freemire

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FDA Recommends that Manufacturers Seeking Medical Device Approval Submit Cyber Security Plans

Last week, the FDA took steps to address a quietly growing concern regarding cyber security and medical devices. Specifically, the agency issued Draft Guidance requiring the submission of cyber security materials as part of...more

6/25/2013 - Cyber Attacks Cybersecurity Data Protection FDA Healthcare Malware Manufacturers Medical Devices

FDA Flexes Mobile App Enforcement Muscles (Gently)

The FDA was granted authority to regulate mobile health care applications (apps) as part of the Food and Drug Administration and Innovation Act. (For a detailed discussion of the FDA’s authority, see “FDA Safety and...more

6/24/2013 - FDA Healthcare Mobile Apps Telemedicine

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