Legal counselling and Medical Devices Regulatory Affairs

Ronen E

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#1
I noticed that lately we slip into discussing this topic more, sometimes derailing threads in a way, so I thought I’d start a separate thread where we can have an ongoing discussion, to which we could also refer users when the topic comes up. At the moment I’ll leave the topic of payment for advice (legal or otherwise) out, because I intend to also start a thread dedicated to that topic (for the same reasons).

The typical scenario is where someone asks a question in RA, then gets an answer along the lines “that’s a question for a qualified legal practitioner”, or someone else answers the original question, either stating themselves “I’m not a qualified legal practitioner”, or a third person joins in and highlights that the answer may be less valid because “it wasn’t provided by a qualified legal practitioner / in a binding manner”. These all boil down to the same few questions, IMO.

Medical Devices Regulatory Affairs (here RA for short) professionals deal with all aspects of applying issued, official regulations. It’s true that RA professionals also touch on voluntary published standards like ISO 13485, official, semi-official and non-official guidance documents, etc. (to varying extents – it depends on the specifics), but these are peripherals. The essence of the profession is the regulations, which are a type of legal instrument in my understanding.

If there’s a need, or a requirement, or an expectation that only qualified legal practitioners deal with legal instruments, then no-one should look to anyone who isn’t such a practitioner, for advice concerning MD RA. Or, at least, any output from such individuals should be run by a qualified legal practitioner before being utilised or relied on. Yet, I hardly know any companies that routinely act this way, and most RA professionals I’ve come across are not qualified legal practitioners. Why is that?

The very essence of the regulations is that one is required (read: expected, sometimes in good faith) to comply with them where they apply. For MD RA, in a great number of instances this is not verified by anyone outside the regulated entity. The other case, which complements the former to make up the vast majority of cases (90%, 95%, maybe 99% - I don’t know; but some figure along these lines), is where compliance is verified with the view not to issue a verdict or prosecute the regulated entity, but rather to practically improve compliance to a point deemed acceptable (according to the regulator / the enforcer, typically ad-hoc). That means that the verification exercise is “forgiving” by nature, in a way, i.e. non-compliance is highlighted in order for it to be fixed. Therefor, the quality (or validity) of provided RA advice (or other RA output) becomes a matter of efficiency, mostly commercial. If an RA professional provides bad advice, it usually won’t be scrutinised through a legal lens, but rather through a practical/commercial one ("how much $$ did this mistake cost us"), and hence the pertinent question would be not whether that professional was qualified to apply a legal instrument (a legal authority), but rather whether they provided their client a reasonably good advice in the capacity they were hired at (to provide commercially-beneficial advice, explicitly taking the regulations into account but not with a strictly-legal view).

I believe that the above view is generally relevant and beneficial outside the USA. I don’t live in the USA, don’t run my business in the USA (though I have USA-based clients and deal with USA regulations), and gladly don’t have too much experience with the USA judicial system, so I’d be glad if others more knowledgeable or more experienced in that context would chip in here, but my impression is that the situation in that jurisdiction is somewhat different, and maybe this is the reason we have this recurring theme at Elsmar (considering its users cohort makeup). First, there is the “cultural” issue of litigation prevalence. Second, the FDA is a law-enforcement agency (very different from an EU NB, for example). So although a big portion of the supposedly-regulated entities are de-facto very loosely regulated (or not at all) – e.g. low-risk device manufacturers – there may still be a more pronounced sense of legal liability around.
 
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