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 titled “FDA Final Rule Reclassifies, Exempts Device Data Systems from Premarket Review.”
According to the rule, published in the Feb. 15 Federal Register (76 Fed. Reg. 8637), FDA is reclassifying medical device data systems (MDDSs) from class III (highest risk, needing premarket approval) into class I (general controls).
Thompson said those companies that have not viewed themselves as medical device manufacturers will need to start developing quality systems and putting in place procedures to report adverse events.
“Whether a hospital designs its system from scratch, or simply modifies it outside of the original manufacturer’s labeling, the hospital has produced a regulated medical device,” Thompson told BNA on Feb. 14.
Thompson said the rule also “seems quite likely to draw in companies that have historically operated on the fringes of regulated territory.”