FDA review process for 510k

The goal of this article is to give a brief idea about FDA 510k medical device submissions process. If a medical device manufacturer wants to sell their medical device in US market then they need to prepare technical dossier, i.e 510(k) which is required by USFDA. 510(k) are the premarket notification which contain technical information, safety information and performance information about medical device. To sell your product legally in US FDA  FDA review process for 510k is needed to review your 510(k) and clear your device. Mostly Class2,Class 3 and IVDs need 510(k)process. 21CFR807 subpart E describes the requirement for 510(k) submission as there is no form for 510(k).US Food &Drug Administration (FDA) is strict about the submission process so it can be challenging for the manufacturer or seller to prepare for 510(k).

FDA review process for 510k medical device submissions:

Process of submission for 510k:

Submitter should start with submitting e-copy of it’s 510(k) to CDRH or DCC (Document Control Center).

 

The chart indicates that  process takes 90 calendar days timeframe ,The submitter expect 7 days for the acknowledgement letter and 15 calendar days for acceptance review decision: substantive review decision within 60 days and final within 90 days. Although this new chart is just a chart and not a track record of FDA review performance, it does provide a much clearer picture of what 510(k) applicants can expect from the US regulator once their registrations get underway.

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