FDA CDRH 510(k) Requirements During Recalls

“510(k) Requirements During Firm-Initiated Recalls ” 11/21/95This document defines 510(k) requirements for changes to fix problems that resulted in recalls. A key concept is that if the change restores the device to its original specifications, rather than altering the device, then a 510(k) may not be required. The relevant excerpt from the guidance is provided below and the full guidance is attached:

“During a recall action, OC’s case officer will review the firm’s recall strategy to determine if the firm’s corrective actions include a proposed modification to the device. In making this determination, OC’s case officer will consider whether a correction alters the device rather than just restoring it to its original specifications. If the correction just restores the device to its original specifications (e.g., a correction involving good manufacturing practices), OC’s case officer will determine that the recall does not involve a modification to the device. In this case, no 510(k) issue is involved and OC’s case officer will process the recall accordingly. On the other hand, if the firm’s recall strategy includes a correction that may alter the device, OC’s case officer will ask the appropriate ODE division to assess whether the proposed modification requires a 510(k) submission”

A flowchart is provided at the end of the document to summarize this process entitled: 510k Requirements for Proposed Fixes to Devices Undergoing Recall “

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