FDA takes a long—and long-term—look at device safety in new plan (via Modern Healthcare)

Fortified's Dan L. Dodson comments on the FDA's Medical Device Security Plan in this Modern Healthcare article.

(Fortified President Dan L. Dodson comments on the FDA’s Medical Device Safety Action Plan in this Modern Healthcare article.)


The Food and Drug Administration appears to be taking a proactive and long-term approach toward improving medical-device safety.

On April 17, the FDA released its Medical Device Safety Action Plan, in which regulators set out their goals for improving device safety, including tracking a product’s safety throughout its life-cycle and catalyzing innovation that will make devices safer.

“Overall, this is a positive step to try to take proactive action to create a better environment for medical devices,” said David Chou, chief information and digital officer for Children’s Mercy Kansas City.

The FDA’s current regulatory framework for devices is from the mid-1970s.

“Safety is an area where there are definitely gaps in device regulation,” said Jim Shehan, senior counsel with Lowenstein Sandler and chair of the firm’s FDA regulatory practice. “The FDA is trying to make the picture better, given the statutory tools that currently exist.”

Updates in the plan include potential initiatives for making sure medical devices are safe, including pushing stronger cybersecurity and implementing a unique device identification system that would track medical devices as they’re distributed and used.

But regulators don’t explain how the unique device ID system would work with existing devices. “The document in general does not address the current in-market devices adequately,” said Dan Dodson, president of Fortified Health Security.


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