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 Politico Morning eHealth, in “International Guidance on Software,” by Darius Tahir, with help from David Pittman and Arthur Allen.
Following is an excerpt:
Epstein, Becker & Green lawyer Bradley Thompson was more positive, though with some reservations. It’s an international forum that developed the guidance — which includes the FDA as a member — strives to harmonize international laws and expectations with respect to medical technology.
But that raises a tricky legal issue: the regulators forum might finalize its guidance, but, Thompson suspects, the FDA must finalize — and seek comment — in its own right.
Aside from that overarching issue, Thompson thinks the guidance could use some tweaks. For example, he says, “[I]t is still difficult … to discern exactly what validation is required for a particular piece of software.”
