Theodore M. Sullivan quoted in article “Medical Device Makers Urged to Beef Up Product Cybersecurity”Bloomberg BNA 12/28/16
Below is an excerpt:
Many in the device industry have urged the FDA to clarify when manufacturers need to notify the agency about software updates that seek to strengthen a product’s cybersecurity, which are constantly evolving based on new information and technology. Some changes made to bolster a device’s cybersecurity could require manufacturers to seek a new market clearance or approval from the FDA, which can be costly and time consuming.
The document should be good for industry, Theodore Sullivan, a Washington-based attorney at Quarles & Brady LLP, told Bloomberg BNA Dec. 27. “It is a pretty common-sense guidance that recognizes the value of permitting correction of most cybersecurity vulnerabilities without undue burdensome reporting requirements.”