FDA issued the document “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”. The exemptions cover a many types of devices. The document is at the link provided.
Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software. Planning, requirements, validation, and submissions – we can assist with all.
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