Overhaul cybersecurity necessity for medical device premarket submissions, Abbreviated and Special 510(k) program clarification, and medical software policy changes having its origin from the 21st Century Cures Act rank highly between topics for a new record of guidance documents the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to produce during the agency’s 2019 fiscal year.CDRH’s new record of final guidance under evolution for 2019 reflects the division’s primary issues in terms of public health and increasing regulatory process planning based on available resources. Advance guidance documents have been assembled into higher-priority (A-List) and lower priority (B List) groups.
Broad topics such as updates to CDRH’s cybersecurity regulatory point of view, Least Burdensome Provisions and benefit-risk determination factors as well as program-specific guidelines layering 510(k), Unique Device Identification (UDI) and other policies transcend the center’s list for the coming fiscal year.
Further high-priority draft guidances planned for the 2019 fiscal year address issues including:
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