FDA 510(k) Submission Process Timeline/Overview

The FDA page at the link provided provides an overview of the 510(k) review process and timeline. It describes the acknowlegment procedure, Acceptance Review, Substantive Review, Interactive Review, AI Request and Decision Letter. It also provides a timeline and indicates all timeframes are in calendar days. Full Manual Link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

Cybersecurity Review

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.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.


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