Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA’s First Pre-Cert Workshops Give Industry and Agency a Chance to Talk,” by Laura Lovett.
Following is an excerpt:
The road to FDA clearance for medical devices may change radically in the next year.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway.
Earlier this week the FDA hosted two workshops to discuss the future of the program with stakeholders. …
While there is general consensus that the FDA needs a new process, exactly how the changes would be implemented is unclear.
“At the end of the day this is an exchange of responsibility. What we are talking about is coming up with a new model that focuses more on the who than the what,” Bradley Thompson, an FDA expert and attorney at Epstein Becker Green, told MobiHealthNews. “From an industry standpoint, the only reason you would be interested in doing that is if it makes your life better or easier, if you can get to market more quickly and without overall increase in cost of doing business.” …
“I think right now the system that we are contemplating is a little bit over the top,” Thompson said. “I look at the assessment model and I see 150 questions on the website. I think that is a lot. That would be burdensome for companies. Would they do it? Well, they might if that made [the devices] freely flow to market.” …
There has also been a lot of discussion around making the program fair for companies of any size.
“I think that is an extremely challenging issue and I don’t know if the FDA has fully grappled with that,” Thompson said. “Is it going to be objective enough? A lot of factors are really ‘squishy. How do you make sure they are treating even similar companies the same way and how do you account for substantial difference and come up with something that is fair?”
