This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at firstname.lastname@example.org.
Dr. Seto received her doctorate degree in Bioengineering from the Georgia Institute of Technology, following a Master of Science degree in Education from Pace University and a Bachelor of Science degree in Bioengineering from the University of California, Berkeley. Song’s academic research background in biomechanics and regenerative medicine prepared her well to review complex and varied pre-market submissions, including 510(k), 513(g), De Novo, and Pre-Submission (including pre-IDE) applications. In her role at FDA, Song reviewed the safety and effectiveness of medical devices such as bone void fillers, bone cements, and soft tissue replacement devices for the Restorative and Repair Devices Branch.
Tell us a little bit about your time at FDA.
I joined FDA, specifically the Center for Devices and Radiological Health (CDRH), in 2014, straight out of graduate school. I was a Lead Reviewer for pre-market submissions in the Restorative and Repair Devices Branch of the Division of Orthopedic Devices, which was a good fit given my research background and interests. I reviewed pre-market submissions independently, as well as managed review teams of subject matter experts. One of the nice things about working at the FDA was the opportunity to participate in various activities and training. I participated in Quality Systems training, worked on authoring guidance documents, helped with biocompatibility training, worked on standards, and had the opportunity to plan a FDA-wide Bone Imaging Workshop for over 180 participants.
What was your favorite thing about working with a review team on a premarket notification or approval submission?
There are a many things I really enjoyed. The level and manner of collaboration were great. For example, I worked with subject matter experts that worked really hard to get me the information I needed within some tough deadlines. While working on a submission, everyone was congenial and had the same goal to review a submission with scientific rigor within the regulatory framework.
I also really enjoyed having a variety of experts on the review teams. Subject matter experts often have had past careers, significant research experience, or a long career at FDA that provides important context when reviewing a submission. There were numerous times I pulled a medical doctor or former veterinarian aside to ask about a certain procedure, and I learned so much from their experience in their respective fields. The wealth of experience and knowledge at FDA was truly remarkable and accessible.
You mentioned you worked as a reviewer within the Restorative and Repair Devices Branch. Can you describe the range of devices your group reviewed?
The Restorative and Repair Devices Branch (RRDB) reviews submissions on orthopedic bone void fillers, polymethyl methacrylate (PMMA) cements, scaffolds with bone morphogenetic proteins, intraarticular hyaluronic acid, and many types of soft tissue replacement devices (many in the concept stage). RRDB also sees quite a few combination products for devices that also have biologic and/or drug actions.
What past experience or trait do you think helped you be a successful reviewer?
I didn’t have much knowledge about medical device regulation before joining FDA, so I had a lot to learn in the beginning. However, I was very open to learning new things and willing to ask questions. In return, I offered my knowledge and experience to help other reviewers. It was beneficial to be detail-oriented and organized, as there was a lot of information to digest. Good writing skills were also crucial, because much of the work as a reviewer is preserved through writing, which will help future reviewers understand the decision process. Although my past research experience did not directly impact my work on a regular basis, it did prepare me to quickly analyze data and understand the scientific principles that the medical device technology was based on.
What are you up to these days?
I am currently a Technical Writer for the Florida Space Institute. I know, very different from my regulatory background! Lately, I’ve been reading and writing about in situ resource utilization and how to get humans deeper into space. I also have a side gig as a Scientific Consultant for a firm who performs research as a federal contractor and prepares many Small Business Innovation Research (SBIR) proposals. When I left FDA, I was looking for a more flexible work option, and the opportunity arose to use my skills in a different field. I enjoy writing and supporting researchers, so personally it was not a huge leap. And like my position at the FDA, my current position requires me to be open to learn and to be an effective communicator. I am not totally over with medical device regulation, however. I’ll be looking into getting back into it soon.
What's something that you learned from FDA that helped you in your current position?
How to manage multiple deadlines. Also, to ask questions that seem pertinent to either understanding the proposal or the premise of the proposal that the principal investigator wants to get across.
How is working in industry similar and/or different than working at FDA?
In my current industry, I interface primarily with research scientists and faculty. Let’s just say that most meetings with scientists and faculty (in Florida, to boot) are much more casual than sponsor meetings at FDA. However, preparing research proposals is similar to preparing regulatory submissions in the sense that many times they are sent to a government agency for review. There is still the need to communicate concisely and effectively.
What is some advice you can give to a person interested in regulatory affairs?
I would suggest speaking to a variety of experts in the field; there are many more aspects of regulatory affairs than just getting a product to market.
For anyone interested in working at FDA, I suggest getting in touch with someone in your network that works there. I learned a lot about the culture and responsibilities of being a pre-market reviewer from a former lab mate, and he was instrumental in helping me join FDA.
For those interested in the FDA, I also like suggesting that they read a history of the agency. There are several well-written books out there that highlight the agency’s role in protecting the public’s health. As a reviewer, gaining a better understanding of the FDA’s mission to protect public health and safety allowed me to keep the greater goals of the agency in mind while working closely with industry to bring innovative products to market.