Bradley Merrill Thompson Quoted in “Lenient Regulations for Digital Medical Devices”BioSpectrum India August 9, 2014
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, was quoted in an article titled "Lenient Regulations for Digital Medical Devices."
Following is an excerpt:
The USA Food and Drug Administration (USFDA) has issued a new guidance that exempts medical devices from its regulatory scope. This means that the makers of these devices, some of which are connected to apps, no longer have to go through the FDA's review process before they bring their product to the market.
"This is big news, and a huge boost to the mHealth industry. It shows that FDA is being extremely practical in reviewing its own practices and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources," said Mr Brad Thompson, Epstein Becker Green compliance attorney. The FDA will now open a 60-day comment period before issuing a final ruling on the matter.