FDA CDRH 510(k) Reqs for Firms Initiating Recalls

FDA Blue Book Memorandum K95-1 “510(k) Requirements During Firm-Initiated Recalls”. Is at the link provided. It explains and provides a flowchart on the options. Note that it indicates FDA needs to be in the loop and agree with choices and approach during a reportable recall.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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