FDA Investigational Device Exemption (IDE)
As a leading regulatory consulting firm, we specialize in assisting with the Investigational Device Exemption (IDE) process. The IDE is a crucial regulatory mechanism granted by the FDA that allows investigational medical devices to be used in clinical studies. The data collected through these studies is essential for supporting a Premarket Approval (PMA) application, which is required for the device to be marketed commercially.
What is an IDE?
An IDE enables manufacturers and researchers to conduct controlled clinical studies to gather necessary evidence regarding the device’s performance and potential benefits for patients. To obtain an IDE, sponsors must submit an investigational plan that outlines how the device will be used in the clinical study. This plan must be approved by an Institutional Review Board (IRB) and, if the device involves significant risks, by the FDA as well.
Classification of Investigational Medical Devices
The IDE regulation distinguishes between studies involving devices with significant risk and those with nonsignificant risk. Significant risk devices, such as implants and life-sustaining devices, require stringent regulatory controls and both FDA and IRB approval. Nonsignificant risk devices, such as daily-wear contact lenses and certain dental devices, only require IRB approval.
IDE Exempt Investigations
Certain categories of studies are exempted from compliance with the IDE regulations. These include the use of legally marketed devices according to their labeling, noninvasive diagnostic devices, consumer preference testing, veterinary-use devices, and devices shipped exclusively for research with laboratory animals.
Who Must Apply for an IDE?
The responsibility of submitting the IDE application to the FDA and acquiring IRB approval lies with the sponsor of the clinical trial. For foreign companies intending to conduct clinical studies in the U.S., it is mandatory to have a U.S. sponsor.
When to Start an IDE Application?
An IDE application should be started before enrolling patients at the study site, especially for significant risk device studies. The sponsor must obtain FDA approval for the IDE in addition to the IRB approvals before commencing the study at any site.
FDA’s Action on IDE Applications
The FDA may approve, approve with modifications, or disapprove an IDE application. The FDA may also request additional information regarding the investigation. The FDA may disapprove or withdraw approval of an IDE application if certain conditions are not met.
Our team of experts is here to guide you through this complex process, ensuring that your studies are conducted in a responsible and transparent manner. Contact us today at info@accelgroups.com to learn more about our FDA IDE services.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
