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[170] FDA recommends that manufacturers submit their cybersecurity management plans as part of their premarket submissions so that FDA can assess whether the manufacturer has sufficiently addressed how to maintain the safety and effectiveness of the device after marketing authorization is achieved

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of this final rule, we finalized revisions to 423.160(a)(5) to specify that prescriptions written for a beneficiary in a long-term care (LTC) facility will not be included in determining CMS EPCS Program compliance until January 1, 2028, and that compliance actions against prescribers who do not meet the compliance threshold based on prescriptions written for a beneficiary in a LTC facility will commence on or after January 1, 2028

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