Earlier this year, the Office of Responsible Research Practices held a two-part webinar series for researchers titled FDA-Regulated Research: Myth vs. Reality – Medical Devices. In this follow-up blog post, we cover where to find session materials and answer questions that we weren’t able to address during the session or that fell outside the scope of the learning objectives.
NEW! Investigator Tools
We encourage all researchers conducting device research to bookmark or download our FDA-Regulated Medical Device Studies: Tools for Investigators packet.
The materials provide step-by-step guidance on how to complete the Buck-IRB application form when a study reviewed by one of Ohio State’s IRBs involves articles regulated by the FDA as medical devices. The format is identical to our investigator tools for FDA-Regulated Drug Research and Collaborative Research.
Session Materials
Part 1: Regulatory Overview (January 2021)
This 90-minute prerecorded webinar reviewed key definitions and concepts related to FDA-regulated medical device research; explained how to determine if a study is Significant Risk (SR), Nonsignificant Risk (NSR), or exempt from IDE requirements; and identified how and when to consult the FDA.
In addition, we used a fictional example of a thermal imaging study to explore how FDA regulations apply to device research.
Part 2: Application & practice (February 2021)
In this live webinar, we applied the regulatory information from Part 1 to real-life examples of medical device research, introduced the five most common medical device research scenarios reviewed at Ohio State, and practiced using the new investigator tools in small groups.
*After the live session, the investigator tools and slides were revised to switch Device Scenarios 4 and 5 (now NSR and SR, respectively) so that the scenarios reflect increasing levels of FDA oversight. Consequently, the slide deck and tools differ from the slides in the recorded video.
All session materials can be also accessed from our Past Educational Sessions page (arranged in reverse chronological order).
Q&A
Q: The IRB confirmed my device study is Nonsignificant Risk (NSR). Does that mean the study is exempt from the IDE requirements?
A: No. NSR studies are considered to have abbreviated IDEs.
This means sponsors and investigators of NSR studies are subject to most of the IDE requirements described in 21 CFR Part 812, even though a formal IDE submission to FDA is not required. The abbreviated IDE requirements are available here.
Q: I’m developing a device that isn’t yet on the market and might change based on study findings. I don’t have a user manual or formal labeling information. What should I provide in the Buck-IRB upload box for “the device manufacturer’s approved labeling?”
A: Provide any available supporting documentation that will help the IRB evaluate the intended use of the device in the research and associated risks. If the device is still in development, a robust description of the device, its outputs, how outputs are generated, the user interface, etc., should be provided. An assessment of potential risks (frequency and severity) should be provided as well. If appropriate, provide pictures or engineering drawings.
Digital health devices that use artificial intelligence or machine learning (AI/ML) can pose particular challenges because the software is unfixed by design. Researchers are encouraged to consult the draft FDA guidance document Software as a Medical Device (SaMD): Clinical Evaluation (2017) when considering what data validation and analysis processes would be helpful in assessing the device. The document also provides a risk structure that may be useful. As applicable, screenshots of user interfaces should be provided. Researchers who are developing or testing SaMD should plan to consult the FDA early in the development process and are encouraged to request a formal risk determination from the FDA; due to the novelty of such devices, the IRB may defer review until the FDA has provided an assessment.
Q: Where can I go for help with the IDE application?
A: At this time, the university has limited resources and expertise available to researchers. The Center for Clinical and Translational Science is a good place to start.
In addition, Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD.org) offers an IDE template, a video walk-through, and step-by-step instructions for completing the IDE application.
Q: I’m planning a study to evaluate a legally marketed device that will be used as approved. The device is marketed under the De Novo pathway, but I don’t see “De Novo” listed as an option in Buck-IRB. How should I list the marketing status in Buck-IRB?
A: Select the radio button for “Premarket Approval (PMA).” In the upload box requesting evidence of marketing approval, provide the De Novo Authorization letter, rather than PMA materials.
Q: How does the FDA define an “adult” for the purposes of medical device research and development?
A: As defined in 21 CFR 814, individuals aged 22 or older are considered adults under federal device regulations; individuals under the age of 22 are considered pediatric patients. Note that this is different than the legal age of majority, which is 18 years in Ohio.
Researchers who intend to study medical devices in an adult population are encouraged to designate 22 years as the lower age boundary of their participant population. Legal adults who are under age 22 (i.e., those aged 18-21) are considered a separate population under FDA regulations; accordingly, a specific rationale and separate risk analysis must be provided when this group will be included in a device clinical investigation.
Q: Where can I find information about emergency use and/or expanded access of investigational medical devices?
A: FDA’s Expanded Access program allows physicians to obtain investigational medical products to treat patients outside of clinical trials in both emergency and non-emergency situations.
Although Expanded Access is treatment and not research, the IRB is still required to provide some oversight of the activity because the investigational agent is not yet approved. Depending on the specific situation, the degree of oversight ranges from IRB Chair concurrence that treatment may proceed to full IRB review and approval of large-scale Expanded Access treatment protocols.
Clinicians who are considering this treatment pathway should contact ORRP’s Expanded Access point of contact, Paul Montesanti, for assistance at montesanti.2@osu.edu or 614-292-9804.
Q: What is a Humanitarian Use Device (HUD)?
A: An HUD is a medical device intended for treatment or diagnosis of rare diseases–specifically, conditions that affect or are manifested in fewer than 8,000 individuals in the U.S. per year. The HUD marketing pathway (called a Humanitarian Device Exemption, or HDE) is less stringent than traditional marketing pathways.
Clinicians considering the use of HUDs should contact ORRP’s HUD point of contact, Paul Montesanti, for assistance at montesanti.2@osu.edu or 614-292-9804.
Q: Where can I find information about completing an initial application in Buck-IRB?
A: A great place to start is our recorded educational session Buck-IRB and Initial Submissions (slide deck here). Our Past Educational Sessions page lists other sessions that may be useful as well.
For Buck-IRB basics, see the resources here.
ORRP also offers remote office hours on Thursdays to assist researchers preparing IRB or exempt submissions. Consultations can be scheduled online and are limited to thirty-minute appointments.