Developing guidance for regulatory submissions

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RAPS (Regulatory Affairs Professionals Society) publish a set of excellent “Fundamentals” books, each covering a different regulatory context: US, EU, Canadian and International (which covers other markets), (see here). These books detail the key aspects of the regulations for pharmaceuticals, medical devices and IVDs (In vitro diagnostics) with considerations about how they should be followed and implemented.  These are essential for healthcare companies looking to make submissions outside of the jurisdictions they are familiar with. 

These books need to be regularly updated as regulations evolve to ensure they are current, and I have been chosen as a subject matter expert for the US fundamentals book that looks at the requirements of the FDA (Food & Drug Administration).  I have recently updated the chapter “supply chain and traceability”, along with a second author, Jyoti Chauhan.

This chapter was initially introduced in the last edition (10th) and so was relatively new to the book. Upon reading, I was most surprised that it did not cover any elements of supply chain or traceability for medical devices, only focusing on pharmaceutical requirements, specifically the Drug Quality and Security Act. I felt the chapter was lacking in detail on medical devices because traceability is a key topic at the moment with the introduction of UDIs (Unique device identifiers) in the last few years, so this was a big gap to be missing.

My first task was to pull together all the existing guidance on the topic of UDIs which the FDA have published as well as the key aspects of the CFR (code of Federal Regulations) in relation to supply chain and traceability. It was interesting to compare them at the same time as different pieces of information are emphasised in different guidance, so I wanted to summarise these in a cohesive overview.

Adapting to the formal writing style of these publications was a practical challenge, but I hope my description and analysis will help other regulatory professionals navigate the tricky waters involved in submitting their products to the FDA for approval.

If you want to know more about these subjects or how CDP can help you with your quality and regulatory activities, then please do get in touch with us at

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Helen Simons

Quality Specialist