Device developers seeking insight into the current thinking of the FDA Center for Devices and Radiological Health as well as those pursuing a career in regulatory affairs have a new resource available. Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, has published Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook.
In addition to his role at Boston Scientific, Wreh is an Associate Lecturer at the University of Akron Department of Biomedical Engineering and part-time lecturer at Northeastern University, covering U.S. and international regulation of medical devices. We spoke with him about his new book and the current challenges facing MedTech regulatory professionals.
What inspired you to write this book?
Wreh: In addition to my work for Boston Scientific, I sit on the FDA advisory committee for industry and teach medical device regulation courses at two universities: Northeastern in Boston and the University of Akron in Akron, Ohio. I also worked at the FDA back in 2011.
The main reason I wrote this book is that I was not a big fan of the textbook I was using to teach my courses, so I decided to write my own. I started working on the book back in 2019. It was a long process. I created a table of contents and then began working on it one chapter at a time. It took about four years to finish the book, which is based on current FDA CDRH thinking on medical device regulation.
How has the regulatory climate for medical devices changed since you started your career?
Wreh: It has changed a lot. The software guidance document has changed. The FDA created the electronic submission for 510 (k), PMA and de novo submissions. By the end of October this year, you will need to submit your 510(k) electronically. Even since I began writing the book, the FDA has released many guidance documents, some of which include guidance on cybersecurity and MR labeling for medical devices.The FDA 510(k) submission guidance document was also updated.
You wanted to look at the FDA’s current thinking in medical device regulation, how is the agency’s current focus different from 10 years ago?
Wreh: One of the biggest changes I’ve noticed is in product approval. Because of MDUFA, the FDA has hired a lot of reviewers to make sure they are reviewing submissions in a timely manner. So, the 510(k) approval process is much better than it was 10 years ago–it was very slow. This did lead to an increase in submission fees because they hired more reviewers. Back in the day 510(k) review was about $5,000, now it’s about $20,000. But the FDA has done a good job on improving the approval process.
Looking at changes at the FDA and with EU MDR/IVDR, what do you think are the biggest challenges for regulatory professionals today
Wreh: The biggest challenge right now is with the EU MDR. A lot of folks are in trouble because many of the smaller notified bodies went out of business with all the new regulations, and that impacted the product approval process in the EU. To get your product approved now with the different bodies, such as BSI, SGS, etc. is tough. You’re talking about at least 12 to 18 months to get approval.
EU MDR represents a completely different pathway to EU approval, and they keep extending the transition period, because no one right now has figured out the regulation. In my opinion, it was a mistake on the part of the EU to not perform more due diligence and to not assess the regulation more thoroughly to make sure all the t’s were crossed and i’s dotted. There are too many extensions happening, so medical device manufacturers continue to have trouble getting their products approved under the new regulation.
Is that due to a lack of clarity in the regulation or a lack of notified bodies or a combination of factors?
Wreh: It is both. The regulations are not clear. No one right now understands the EU MDR. When the FDA issues a new regulation, they know exactly what they are talking about and they know how to go about implementing it, but the EU missed the calculation.
The FDA is pretty good about, when they issue a new requirement, they know how to go about it. They talk to sponsors, applicants and manufacturers to identify the problem and provide guidance. The FDA may not be perfect, but I think they are one of the best regulatory agencies in the world, because when they issue a new regulation, it’s pretty clear. The EU regulations are too muddy right now.
Do you have any advice in terms of how best to communicate with regulators if you do need clarity or have concerns?
Wreh: In the U.S., Advamed works with most of the big device manufacturers and is an advocate for the industry. So, when the FDA is going to release a new regulation, they speak with Advamed to get our input. That is not the case in the EU, they just do it. In the U.S., we know what’s coming.
You mentioned that you wrote your book to have a better textbook for your students. Is this book primarily intended for regulatory science students or also for more established regulatory professionals?
Wreh: It’s for a wide range of folks. It’s not just for those who want to be regulators or regulatory professionals in industry. It is for everyone in the medical device field—CEOs, salespeople, marketing, Quality and R&D, and also law students interested in medical device regulation. If you want to sell medical devices in the U.S., this book can help you prepare and understand the process. It is open to everybody.