Studies testing the safety and/or effectiveness of a medical device are regulated by the Food and Drug Administration (FDA). Depending on the risk classification of the device being tested, a submission may be needed to the FDA prior to any human subjects research takes place. Additionally, specific requirements regarding the development, manufacturing, documentation, as well as other specific requirements may be needed to comply with the FDA regulations and law. Therefore, we offer support to Georgia Tech faculty, students, and staff in complying with all applicable regulations and laws. Please see the FAQs below for more detail.
What is considered to be a medical device?
The FDA defines a medical device in Section 201(h)(1) of the Food, Drug, and Cosmetic Act as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o)."
When should I get Regulatory Affairs involved?
It is highly recommended to engage with the Regulatory Affairs and Clinical Trials team early on in the study design process. The Regulatory Affairs and Clinical Trials team can identify possible challenges that may need to be addressed prior to submitting funding proposals and/or submitting to the IRB for review. Thees challenges can both delay the start of the study and add unexpected costs.
Does my study need an IDE?
Studies testing the safety and/or effectiveness of a medical device are subject to the IDE regulations in 21 CFR 812. Studies meeting the IDE exemption criteria do not require an IDE. Studies that are not IDE exempt require either an abbreviated IDE (IRB oversight only) or an FDA-approved IDE depending on the risk level of the study (nonsignificant risk vs. significant risk). The IRB will determine if and what type of IDE is needed during the study protocol’s full board review, but the Regulatory Affairs and Clinical Trials team can provide a preliminary assessment of whether the study may meet any of the IDE exemption criteria or if a risk assessment by the IRB may be necessary. Alternatively, the Regulatory Affairs and Clinical Trials team can assist with submission of a study risk determination request for a binding assessment from FDA on whether the study requires an IDE.
Who submits an IDE to the FDA?
The Principal Investigator, a regulatory coordinator, the sponsor, or another designated study team member can create the IDE submission for FDA review. However, the Regulatory Affairs and Clinical Trials team must review and submit all Georgia Tech sponsored IDEs and subsequent reports, supplements, and amendments to the FDA.
How does Regulatory Affairs support the manufacturing process?
If specific controls are needed for the manufacture, testing, and changes to a device, the Regulatory Affairs and Clinical Trials team will help the study team identify an appropriate third party firm to meet comply with what is required. What is required may vary on the risk of the device and how the device operates. Please contact the Regulatory Affairs and Clinical team early in your design process so that the team can identify what controls are needed and provide a path on how to comply with them.
How does Regulatory Affairs support the IRB process?
The Regulatory Affairs and Clinical Trials team does not submit IRB submissions on behalf of the study team. However, we are available for both in-person and virtual meetings to work through the submission and provide support when completing the submission and responding to the IRB.
When do I report adverse events to the FDA?
Unanticipated adverse device effects must be submitted to the IDE in addition to the IRB. “Unanticipated adverse device effect” means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
The sponsor should report unanticipated adverse device effects to the FDA and all reviewing IRBs and participating investigators within 10 working days after the sponsor first receives notice of the effect.
If submitting an Adverse Event report to the FDA for an IDE, please contact our office prior to submitting.
Does Regulatory Affairs help with FDA meeting submissions?
Yes, the Regulatory Affairs and Clinical Trials team supports Q-submissions. Pre-submission meetings are used to solicit feedback from the FDA on safety and performance testing requirements, preclinical and clinical study designs, potential predicate devices, and more. Please contact us as soon as possible if you would like to submit a meeting request to the FDA. The Regulatory Affairs and Clinical Trials team must review and submit all GT-sponsored FDA meeting requests.
Does Regulatory Affairs help with marketing applications?
As employees of a nonprofit research university, the Regulatory Affairs and Clinical Trials team's focus is on supporting research rather than marketing applications. If you believe support of your marketing application is within GT’s mission, please reach out to us for further discussion.