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 FierceHealthcare, in “FDA Seeks Input on Software-As-A-Med Device Regulation,” by Susan D. Hall.
Following is an excerpt:
“This is really huge, much bigger than many people might appreciate,” Bradley Merrill Thompson, an attorney with Epstein Becker & Green, said in email to FierceHealthIT.
It would apply to a huge number of mobile apps, as well as stand-alone programs for PCs used in healthcare, Thompson said. Since clinical evaluation is typically the most expensive part of product development for them, the requirements will have a significant impact on the cost and time to market involved in developing them.