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 Healthcare Dive, in “FDA Clarifies When to Submit 510(K) for a Software Change,” by Meg Bryant.
Following is an excerpt:
The Food and Drug Administration issued final recommendations on when a modification to medical software requires new 510(k) clearance.
The guidance, published Wednesday, discusses common types of software changes that could necessitate a 510(k) filing: infrastructure, architecture, core algorithm, and reengineering or refactoring. Two other types of changes — clarification of requirements and cosmetic changes — would likely not require a new submission if they don’t impact the device’s functionality.
While welcome, Epstein Becker Green partner Bradley Merrill Thompson told MobiHealthNews the new guidance doesn’t go far enough. “If it’s an improvement, it’s only a marginal one,” he said. “Until we change the regulation and shift the agency’s focus to the software vendor, rather than engaging individual product review, any gains will be small at best.”
