Over the years, I have frequently urged medical device professionals to take advantage of the different seminars and public meetings offered by the FDA. As a reviewer, I would often wonder why the submission on my desk was lacking the specific required protocols, validation parameters, or clinical data that could have easily been conducted and reported properly prior to submission, and I would often refer the submitting regulatory specialist to the specific training required to complete the submission. These regulatory submission holes often resulted in lengthy application delays with Additional Information letters as companies gathered the missing product information through additional bench or clinical testing. The parameters of most required verification and validation testing are usually covered in the training seminars offered on the FDA’s Training and Education website.
Many of the training seminars are offered as online video presentations with PowerPoint slides and walk the viewer through various topics—everything from the basics of a 510(k) submission, to registration and listing mandates, to specific validation requirements for new medical device clearances. As a reviewer and FDA employee, I always made it a priority to attend these events in person or watch the live stream online of any seminar of interest to my position so I could stay abreast of the agency’s and medical device community’s latest thoughts and policies. With the frequency of new draft guidance documents and de novo classifications released by the FDA, it is extremely important for professionals involved in design history, regulation, quality management, and post-market surveillance to remain educated and informed of new and emerging FDA perspectives, especially concerning the medical device products designed and marketed by their company.
The following is a review of the different types of educational opportunities offered by and in conjunction with the FDA, all of which can be found on the agency’s website www.fda.gov/Training
FDA Guidance Webinars
The FDA will often offer webinars when a new draft guidance document is issued. The webinars allow the public an opportunity to comment, ask for clarification, and collaborate on the new draft guidance during the 60-day comment period, during which the FDA collects public opinion on its proposed guidance. The webinars are a necessity for medical device companies that develop and manufacture the specific products discussed in the draft guidance document. The FDA reviews public comments when revising the draft guidance document, so it is important that the medical device community offers its thoughts before the final version. Although the live webinar occurs only once, all webinars are archived for future viewing; included in the archives are the webinar video, a closed captioning transcript of the presentation, questions submitted during the webinar, and PowerPoint slides of the presentation.
The CDRH (Center for Devices and Radiological Health) Learn Portal offers numerous transcripted training presentations with videos and printable slides. The presentations are divided into topic modules that cover everything from the basics of registration and listing to specialty technical topics such as biocompatibility assessment using ISO 10993-1. For example, designers of a novel implantable orthopedic device requiring clinical testing would benefit from a sub-module with 13 presentations on Investigational Device Exemptions. These presentations are invaluable tools for design and development of medical devices and post-market activities, and can be viewed at any time.
Meetings, Conferences, and Workshops
The FDA provides a list of all upcoming and past workshops, meetings, and conferences it sponsors. These events usually cover new and emerging technologies, trends, and concerns, and enable the medical device community to interact with the FDA to learn the agency’s position on these issues. The listing for upcoming events includes basic information like location, time/date, registration specifics, agendas, speakers, and webcast data. The list of past events includes videos, presentation slides, and transcripts of each event. One recent public workshop held in April this year discussed the development of Orthopaedic SMART (Sensing, Measuring, and Advanced Reporting Technology) devices. The following medical device event (pulled from FDA’s website) provides a good example of the kind of data included in an event listing:
|Public Meeting – Pediatric Medical Device Development – August 13-14, 2018, from 9:00 a.m. to 5:00 p.m., FDA White Oak Campus. This meeting will discuss strategies to enhance the development of medical devices that serve the specific and complex needs of the pediatric population, including infrastructure of pediatric clinical studies, appropriate use of data extrapolation, better and appropriate use of post-market registries, enhancing and increasing the assistance provided to pediatric device developers by the FDA, and identification of current pediatric device development barriers.|
FDA CERSI Co-Sponsored Lecture Series and Workshops
The FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSI) are collaborations between the FDA and academic institutions such as Johns Hopkins University, the University of Maryland, Georgetown University, Yale-Mayo Clinic, and UCSF-Stanford. The CERSI collaboration was developed to nurture a regulatory science culture that can address the challenges of medical device development. CERSI offers courses, workshops, and seminars to the medical device community that cover specialized topics including emerging safety and efficacy issues the regulatory community encounters from the development of new, innovative technologies. Events have included topics such as pediatric master protocols, national evaluation systems for medical devices, and breakthroughs in novel medical device materials. In the past, the CERSI has held the Clinical Investigator Training Course, which is a three-day training workshop designed for professionals involved in clinical trials, covering topics ranging from regulatory requirements and study design to safety and ethical considerations related to the performance and evaluation of clinical studies. The following listing details an upcoming event of interest:
|Patient Engagement in the National Evaluation System for Health Technology (NEST): Lessons Learned and Best Practices – September 12, 2018, University of Maryland. This workshop will cover experiences and best practices for patient engagement in evidence generation such as planning, data collection, data analysis, and information dissemination for medical devices or combination products.|
Other Educational Opportunities
The FDA is not the only source of educational opportunities available to the medical device community. Several organizations offer professional development in the forms of conferences, webinars, and online training courses. The AAMI (Association for the Advancement of Medical Instrumentation) offers a myriad of training courses and certifications available for anyone interested in learning more about medical device design and regulation. The organization’s website allows interested parties to apply for classes through the AAMI University on topics as broad as Medical Device Classification and as specific as methods for handling a small clinical sampling size in data analysis. The AAMI website also offers industry training courses, in which FDA representatives are available for comments and questions throughout the class.
Medscape is another online source for educational opportunities, focusing on continuing education for professionals to fulfill licensure requirements. Although Medscape is more clinically oriented, it sometimes offers training and publishes articles relevant to orthopedic device regulation.
The 13th Annual FDA Inspections Summit is another great opportunity to receive training. This annual conference offers seminars on clinical trials, regulatory affairs, Quality Assurance/Quality Control, manufacturing/Good Manufacturing Practices, and medical device development. This conference not only covers FDA regulations and inspections, but the European Union’s Medical Device Regulation as well. This conference is not just for specific individuals who handle FDA audits and inspections. Every professional involved in the device design and document history, quality management, and regulatory aspects of product development should attend this event to learn how their role in medical device manufacturing impacts an FDA inspection or audit. This year’s annual conference will be held Oct. 23-25 in Bethesda, Md. To register for the summit, call 703-538-7600; 888-838-5578, or visit www.fdanews.com/fdainspectionssummitRegister.
The Global Summit on Regulatory Science (Sept. 26-27 in Beijing, China) is another conference that offers opportunities for additional training. This international conference will include discussions on global regulatory applications of basic and emerging science, allowing academic, industrial, and regulatory agencies to engage in conversations as well as collaborate on global harmonization. Although this year’s topic of discussion will focus on dietary supplements and herbal medicine, each year a new focus topic is chosen, so this conference is definitely one to keep tabs on.
Elizabeth O’Keeffe received her bachelor of science degree in biochemistry from Denison University and has a Ph.D. in analytical biochemistry from the University of South Carolina, where she focused on advanced glycation end products in diabetes research under Dr. John Baynes. O’Keeffee followed up her doctorate with a postdoctoral fellowship in clinical chemistry in the Laboratory Medicine department at Vanderbilt University Medical Center. She then worked as a scientific reviewer for the FDA in the Department of Chemistry and Toxicology Devices, OIR, CDRH, before becoming the director of Engineering and Technical Services at Secure Biomed Evaluations.