FDA Issues Guidance Documents on 510(k) Requirements for Changes to Medical Devices
The Food and Drug Administration issued two guidance documents to clarify when a new 510(k) premarket submission is required when changes are made to existing medical devices. One new guidance document explains when software changes to existing devices require submission…
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of a new 510(k). FDA also updated an existing guidance document on when other types of changes to existing devices require a new 510(k). The guidance documents are “not intended to implement significant policy changes to FDA’s current thinking on when submission of a new 510(k) is required” for changes to existing devices, the agency said. The guidance documents are instead intended to “enhance the predictability, consistency, and transparency of the 'when to submit' decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision, specifically as it relates to software changes,” it said.