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 the Bloomberg BNA Medical Devices Law & Industry Report, in “Bipartisan House Bill Would Ease Device-Accessory Reviews,” by Mike Stankiewicz. (Read the full version – subscription required.)
Following is an excerpt:
The 21st Century Cures Act, signed into law in December 2016, ordered changes to the review process and directed the FDA to classify accessories independent of their parent devices.
“The FDA does currently have the ability to create appropriate risk-based classifications already, without additional congressional approval,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA April 26. “There are also about five other classification processes that they could use. What this bill adds is three or four other, particularly tailored processes to use.” Thompson is a Bloomberg BNA advisory board member.
The bill would allow manufacturers to recommend a new device’s classification based on data supplied during the application process. It would also authorize the FDA to re-classify device accessories already on the market.