Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article stating “Device Data Systems: What the New Rules Leave Out.”
According to the article, the FDA released its ruling for medical device data systems (MDDS) in February. Devices under that category have officially been reclassified from Class III to Class I devices. This is good news for companies whose products were already being evaluated by FDA as MDDS—it eases their regulatory burden. For other companies, the rules present some complications.
“The changes FDA made to its proposed MDDS rule simultaneously enlarge the MDDS category to capture more software that we might have assumed would be unregulated, but also enlarged the MDDS category to capture software that might otherwise have been placed in class II or III,” noted Thompson.
Thompson noted, “FDA has published just one piece of a puzzle, only the rabbit’s nose, and we have to use our imagination . . . to see the rest of the rabbit.”