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 BNAin 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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.