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 Finalizes New Guidance to Support Medical Device Innovation and Ease Burden of Software Updates,” by Evan Sweeney.
Following is an excerpt:
The Food and Drug Administration is rolling out a handful of new guidelines aimed at fostering medical device innovation by allowing manufacturers to make small iterative modifications to their products and software. …
But the guidance documents may only provide marginal relief given the stringent regulations that are still in place, according to Bradley Merrill Thompson, a medical device attorney with Epstein Becker & Green. …
For the mHealth industry, the finalized guidance on 501(k) submissions for software changes is perhaps the most notable, Thompson said in an email to FierceHealthcare. He added that developers are not as put off by the idea of getting FDA approval for a device as they are about resubmitting their device for every software update.
“Software development is highly iterative based on feedback, and the idea of seeking FDA clearance for every improvement makes many entrepreneurs sick to their stomachs,” he wrote.
