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News From the Food and Drug Administration
March 1, 2016

Making Devices Cyber Safe

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(9):861. doi:10.1001/jama.2016.1283

Medical device makers should address cybersecurity safeguards throughout the life of their products, according to recent draft guidance from the FDA. The proposed recommendations apply to devices that contain software or programmable logic, but not to investigational or experimental devices (http://1.usa.gov/1Q3wxyr).

The agency noted that manufacturers should address the potential for cyber threats during initial product design and development. However, postmarketing cybersecurity risk management programs are essential, the FDA stressed.