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.