Une mise en demeure de la FDA pointe une mauvaise appréciation du risque...

Dans cette "warning letter" adressée à une société fabricante de dispositifs médicaux, un écart porte sur la minimisation d'un risque de surdosage sans justification argumentée : 

3.    Failure to establish and maintain adequate procedures for validating the device design, including risk analysis, as required by 21 CFR 820.30(g). For example, your risk assessment, #(b)(4), dated February 4, 2013, for “GemStar Backward Motor Movement Issue for Overdose” is inadequate in that the risk level was calculated to be Acceptable with Justification (AWJ); however, the risk assessment does not document the reasons why the risk level is AWJ when the risk assessment indicates that there are no design risk control measures in place that mitigate the hazard of overdosing. 

 

We have reviewed your response and have determined that it is inadequate because your response does not include rationale as to why the risk analysis was determined to be Acceptable with Justification when your firm had no measures in place to mitigate the risk which has the potential for patient overdose.

Cette remarque rejoint celle du guide PIC/S PI011 (14.3) :

The risk analyses and the results, together with reasoning for critical or non-critical classifications, should be documented. Risks potentially impacting on GxP compliance should be clearly identified.

Plus d'information ici.