If the pilot works out, sponsors will be allowed to submit premarket applications using a cloud server in addition to mailing paper copies of their documents.
Mailing premarket applications on CDs, DVDs and flash drives alongside paper copies may become a thing of the past if a new US Food and Drug Administration pilot program is successful.
On 6 October, the FDA announced the immediate launch of the Electronic Delivery of Premarket Submissions Pilot Program, which...
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The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
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