Bradley Merrill Thompson Quoted in “FDA Gives Advice on Getting Innovative Devices to Market Faster”Bloomberg BNA Medical Devices Law & Industry Report October 31, 2017
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 “FDA Gives Advice on Getting Innovative Devices to Market Faster,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Medical device companies are getting more guidance from the FDA on how to use an alternative pathway to get innovative products on the market faster. …
One issue with the pathway is that the first company that pursues a de novo creates an easy pathway for competitors to follow along at much less cost to them.
Bradley Merrill Thompson, a Washington-based health-care attorney with Epstein Becker & Green PC, told Bloomberg BNA in an Oct. 27 email, “the problem with the de novo process is it requires a big, kindhearted company to absorb the cost of the regulation for all of its competitors, all within the capitalistic framework” and “that’s asking a lot.” Thompson also is a Bloomberg Law advisory board member.
“As the cost and burden of submitting a de novo approaches that of a PMA, companies will find it better to pursue the PMA because the results of that exclude competitors,” Thompson said. De novos became more expensive for fiscal year 2018 because device makers now have to pay a user fee for de novo submissions. For FY 2018, the standard fee for de novo submissions is $93,229, and the de novo fee for a small business is $23,307. A small business is defined as a business that reported $100 million or less of gross receipts or sales in its most recent federal income taxable year.