Should the FDA review process be more relaxed in favour of faster review times at the expense of potentially greater impact to the well-being of patients when a device does fail?
The short answer is, “Of course not!” Relaxing the review process is not the answer. However, there are tools and techniques already in the device developer’s arsenal of which the FDA should be requiring more rigorous use. Patient risks are the first and last things that device developers should be assessing in Hazard Analysis. If this effort is honest and rigorous, the hazards can be mitigated or dealt with in the development effort.
Hazard Analysis and it’s related technique, Failure Modes and Effects Analysis (FMEA), are living processes that should commence at the requirements definition or feasibility stages, and be upgraded regularly throughout the development cycle. The FMEA(s) should incorporate the design (dFMEA), the instructions for use (uFMEA), and manufacturing process (pFMEA). These allow the development team to assess the impact of failures of design, use, or manufacturer with regard to patient safety and other hazards (like the user, operator, calibrator, or assembler).
The FDA can and should adapt a more sophisticated approach to evaluating the QSR artifacts that developers submit in either 510(k) or IDE/PMA submissions. If the Hazards Analysis is “light,” then a reviewer should become even more vigilant.
We suggest that applying the rigour that these well-established engineering disciplines invoke should enable faster review of “good” submissions (meaning those that follow the discipline rigorously and respond to the findings throughout the lifecycle), and more robust identification of “bad” ones (where the real hazards are not recognised or underrated) before being presented with incidents, complaints, and MAEs. And this, after all, is consistent with the FDA mandate.
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