From: FedScoop
The draft would update a guidance issued in 1997 — “a millennia ago,” as one expert joked.
By Whitney Blair Wyckoff
The Food and Drug Administration released new draft guidance to help clarify when makers of certain types of medical devices may need additional clearance for a software update.
Unveiled this week, the draft applies to medical devices, like MRI machines, that were put through FDA’s 510(k) submission process — a pathway, meant for products that pose a medium-to-low risk to patients, that requires manufacturers to demonstrate their product is “at least as safe and effective” as similar devices already on the market. The draft lays out under what circumstances makers of these devices would need to file another 510(k) submission to account for a change.
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