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Recalls:  One Procedure May Not Be Enough

It used to be that a single procedure aligned with 21 CFR 7 was sufficient when it came to medical device recalls.  In the "good old days," if you and your company were lucky, the only person interested in this procedure was the FDA GMP inspector.  If you had the document, it was aligned with part 7, and you didn't have a recall situation, then case closed, and most likely the inspector moved on.   However, that was BEFORE quality systems/EC certification audits by Notified Bodies, the European Vigilance Guidance, and the MDA Guidance on the Recall of Medical Devices for example.

European requirements notwithstanding, for most manufacturers in regulated industries, once the procedure is in the manual, most regulatory professionals "don't go there" again unless they have to.  There is still a stigma associated with "the 'R' word" so that it is just something not addressed after the initial SOP is issued.   After all, a revision on the Recalls SOP may invite some additional questions from the CEO or COO based on realization of their responsibility specified in the procedure.  A CRO Group partner recently performed an IVD company quality system audit, and found that the whole organization had changed and the Recall SOP was for a division of the company that was sold 5 years ago!  Although it sounds ridiculous, you never know what you may find when you dust off the Recall SOP especially if your company has been fortunate.

Until recently, the only European document that addressed recalls, and then only sparingly, was the European Vigilance Guidance.  Then, the UK MDA (Medical Devices Agency) published "Guidance on the Recall of Medical Devices."   This document picks up where the Vigilance Guidance leaves off.  It refers to the Vigilance Guidance, and, in our opinion, represents the first EU Competent Authority going on the record as to what it expects from medical device manufacturers when a recall needs to be executed.  In several respects, the Recall Guidance has taken into account recall mechanisms,that FDA has provided in its recent guidances, such as inventory accounting for recalled batch quantities, and the sending of communiques to the recalled device physician and or patient.

A reading of the Vigilance Guidance and the Recall Guidance should bring one point home, and that is, EU recall requirements are not the same as those specified in part 7.   So, don't be surprised if on a quality system audit your Notified Body auditor asks you for your Recall SOP.  Chances are, if it hasn't been revised in the past 3 years, you're going to get an observation because the EU Vigilance Guidance recall requirements, and now the UK Recall Guidance have been published during that span.  Moreover, if your Recall SOP hasn't been revised in the past 5 years, there's a chance it does not take into account the expectations of FDA for 510(k) devices  which were clarified in a 1995 Blue Book memo.

All of these documents, including the EU Vigilance Guidance, the UK MDA Recall Guidance, as well as "Methods for Conducting Recall Effectiveness Checks" and "510(k) Requirements During Firm-Initiated Recalls" are available at no extra charge to StdsRadar subscribers.

If you would like to have a CRO Group partner assess your Recall SOP for conformance with USA, EU, or any other regulatory agency, please send us a short email. 

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