Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in this week’s FDA Week newsletter, in an article titled “CDS Coalition to FDA: Craft Plan to Classify New Health Information Tech.”
Following is an excerpt:
“For those companies making FDA regulated software, there’s no way to move forward with new technology without classifications. Unfortunately, FDA generally treats this as simply a money issue, saying they don’t have the human resources to produce the needed classifications and that industry will have to do the legwork in putting together de novo requests,” said Bradley Thompson, an attorney with Epstein Becker & Green who serves as regulatory counsel for the CDS Coalition.
He continued: “The proposal which I sent to FDA describes a role the agency could play with only minimal time and effort.”