Regulatory Isn’t a Foreign Language, it just seems that Way

By: Robert O. Dean

Regulatory Isn’t a Foreign Language, it just seems that Way, why? Let’s take the easier topic first, business plans and strategies. Typically, these discussions are reduced to the most easy and practical concept, money! We all understand how to gauge and understand the opportunity and use of money. Describe an opportunity, what needs to happen to capture that opportunity, what is the expected result of that opportunity, measure the result, e.g. count the money. Simple, so to say.

Now why does the “regulatory process” seem like a foreign language. First let me describe the “regulatory process” at a high view level…

National Laws➨ Regulations➨ Standards➨ Standard Operating Procedures/Protocols➨ Records/Reports

        (the “must do law”) ➝ (the law detailed) ➝ (the compliance requirements) ➝ (the how to do it) ➝ (the proof that it has been done)

Five levels of technical words and requirements with each level becoming more technically written and defined. To work your way through this process indeed becomes a foreign language. Especially when a company is conducting business on a worldwide basis, since each country has its own national language, interpretation and requirements. Over that past 20 years many of these regulations have been “harmonized” among many nations with the intent to provide for a “common understanding and language” of the regulatory requirements in order to simplify compliance. Not always the case. In many countries there always seems to be an added nuance to their national regulation, either taking some element out of the regulation, however in most cases adding some additional element which turns into an auditor “gotcha” moment. This is where regulatory language becomes very difficult.

Now, where does the real “foreign language” occur? As shown above there is typically five levels within the regulatory process. Usually hundreds of pages and at times thousand of pages. In order to allow regulatory and quality professionals to navigate through theses pages a type of printed and verbal shorthand has been “applied” but not codified (like a language dictionary). This “shorthand language” are the use of acronyms. Acronyms are an abbreviation formed from the initial letters of other words and pronounced as a word and most time just cited as a three letter “term’ i.e. FDA, Food and Drug Administration.

So, this is what happens, writing or speaking a regulatory requirement using commonly applied acronyms.

For example; “The US FDA now requires compliance to the QSR RA/QA regulation for MDR to include feedback loop to ISO 14971 to reference CAPA activities which may affect DHFs, 510Ks, TFs and DMRs with approved objective evidence documented on ECR/DCO to be retained in the DHFs, DHRs following approved SOPs including V&V protocols and reports, this RA/QA requirement is also applicable within the EU MDR.”

Twenty plus acronyms used in one regulatory statement!

Interpretation: “The United States Food and Drug Administration  now requires compliance to the Quality System Regulation  Regulatory Affairs/Quality Assurance regulation for Medical Device Reporting to include feedback loop to International Standards Organization Medical devices — Application of Risk Management to Medical Devices  to reference Corrective Action Preventative Action activities which may affect Design History Files, Premarket Notifications, Technical Files and Device Master Records with approved objective evidence documented on Engineering Change Record/Document Change Order to be retained in the Design History Files, Device History Records following approved Standard Operation Procedures including Verification & Validation protocols and reports, this Regulatory Affairs/Quality Assurance requirement is also applicable within the European Union Medical Device Regulation framework.”

So, the acronym verbal shorthand reduces the text by 44%! No dictionary, no explanation of terms, yes, a foreign language to the uninformed and unpracticed.

Glazed over just reading this article? Try working your why through the new European Union Medical Device Regulation (MDR, 348 pages) with corresponding Quality System Manual (QSM, +200 pages) and do not confuse the EU MDR (Medical Device Regulation) with the FDA MDR (Medical Device Reporting).

Regulatory Isn’t a Foreign Language, it just seems that Way, that’s because we (RA/QA professionals) have made it that way in order to be more efficient in our compliance program dialog. Sorry and bear with us, and don’t hesitate to demand during the next compliance meeting “what the heck are you talking about, can you speak in a common language!” Ugh, it will not be the first time I have been asked or the last.

 

Biography of Robert O. Dean

As the Director of Regulatory Affairs and Quality Assurance, works with customers, US Team and the China team developing and implementing quality systems and device design protocols and validations to assure specification and national regulatory compliance and certifications.
Robert has +40 years’ experience in the pharmaceutical, medical device, and cosmetic industries, focused on the areas of development, regulatory, manufacturing, quality and business management.
Robert has 5 active medical device patents, +50 governmental approvals, and world wide experience with medical device development, manufacturing and compliance.
In his free time Rob can be found hiking, cycling and kayaking, preferably above 8000 feet. At sea level, exercising, surfing, competitive driving and “wrench turning”.