A review of “US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States”

This was a paper written by Christa Altenstetter in 2013.  Professor Altenstetter focus is on the politics of healthcare.

It examines the development of the US and EU legislation and how although they are similar there are significant differences.  The paper identifies three myths concerning the FDA;

  1. The FDA is seen as a world leader in drug regulations when for a lot of initiatives it has followed other regulatory regions such as UK and Canada.
  2. The FDA is not a leader in device regulation with its use of 510(k) as regulatory path but that the EU decentralised approach also fails to meet expected patient safety.
  3. That arbitrary decision making process of the FDA has led a lot of US companies to turn to Europe as it is perceived to be more predictable and less costly.

There are two other interesting points made by the author which relates to both regions.  Drug regulation is stricter in both regions compared to medical device and the understanding of what risk is depends on the cultural, political as well as the regulatory aspects of both regions. In regulatory approach for high risk devices the EU depends on the manufacture’s claim of performance while the US focuses on effectiveness with neither considering the input from clinical research.

She also deals with one of the key aspects of my research in that she considers the drug/device combination products particularly as the devices become more complex.  Indeed she highlights that Feldman et al consider drugs and medical devices  as an “Artificial distinction” and a “historical and legislative artefact”.

This is my first realistic attempt to properly review a paper. It required me to read and highlight what parts I was interested in.  I used Highlights.app which allowed me to highlight sections according to Important (Red), Interesting (Yellow) and For Information (Green). This meant when I was finished I had a summary of the document which I can also save and refer back to. As a first attempt to properly review something it was not a bad attempt and I could acknowledge the benefit as I was actually reading and noting to understand.  This next step of writing down my interpretation also helps the transfer of knowledge.  It is a slow process but it was worth it on a significant paper such as this which will have an impact on my own research.  It is always good to have a few seminal pieces which act as signposts.

What I have taken from this paper is an acknowledgement of my own bias with relation to the FDA. As a person who has operated within a FDA environment for over 20 years my perception was that it was a leader in regulatory practise. In my formulation of my research as I was focusing on the EU MDR it seemed natural to presume that the centralised FDA approach was correct/better the decentralised European MDR.

The paper provides substance for two or three possible interview questions ;

  1. Do people consider the US FDA regulatory path easier than proposed MDR approach
  2. Should drug-devices be considered as one entity and therefore only by one entity.
  3. Do you consider there is different perception of risk between US and EU regulators.

I hope that I can streamline this review approach over at least 10 good papers. This one was a calculated “shot in the dark” just to get a feel for the process. I need to develop a structured collation process.

Altenstetter, C. (2013). US perspectives on the EU medical device approval system, and lessons learned from the United States. European Journal of Risk Regulation4(4), 443–464. https://doi.org/10.1017/S1867299X00003093