Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Group Calls for Classification Clarity Before Clinical-Decision Support Guidance."
Following is an excerpt:
"In my private practice, I'm getting all sorts of companies that are coming to me with really beautiful software and saying Brad, 'How is this classified?' And my answer to them has to be, 'I don't know. So far it seems it hasn't been classified,'" Thompson told "The Gray Sheet." "They're really, really struggling."
Thompson says his clients generally anticipate that their software will be considered to be a medical device and are willing to use quality systems to oversee that their product aligns with FDA's regulatory needs. However, he says filing a PMA in situations such as for software that only advises patients would be "downright stupid."
"Nothing's going to happen in this space without classifications," he added. "You can't bring new products to market if you don't know how FDA will regulate them."