Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Loosens Controls on Some Low-Risk Devices,” by Mike Stankiewicz. (Read the full version – subscription required.)
Following is an excerpt:
The exemptions for the selected devices won't help the industry or the FDA as much as intended, Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA April 12.
“The purpose behind this is to lessen FDA's workload, but a lot of these devices haven't been active since the 1980s,” Thompson, a Bloomberg BNA advisory board member, said. “I found very few with submissions from this decade. While this looks good on paper, it doesn't lessen anyone's workload. They are old technology that no one is using anymore.”
“This will help some,” Thompson said, “but as far as the FDA balancing its budget, it's pretty nominal.”
