Ask the Experts: Applying for INDs, IDEs or Exemptions
This monthly feature presents questions from clinical trial professionals with answers from WCG’s expert staff. This issue features insights from WCG IRB Regulatory Chair Ranga Venkatesan, IRB Medical Vice-Chair Geoffrey Browne and Regulatory Chair Director Sheri Spivey.
Question: What information do I need to submit regarding the regulatory status of my investigational product?
Answer: If an investigational drug, vaccine or biologic is being evaluated for safety and efficacy, the study requires an IND application from the FDA or an exemption.
The sponsor should provide the IRB with the IND number on a sponsor document, e.g., the protocol or a separate sponsor letter, an FDA letter with the IND number, or documentation from FDA that an IND is not needed. If the sponsor believes an IND application is not required, documentation of the rationale for not needing an IND and the regulatory status that should be applied is also needed.
To apply for an IND, complete an FDA Form 1571, append the protocol and, if applicable, provide a rationale for not needing an IND and submit that to the FDA. By law, when a 1571 is submitted, the FDA must respond within 30 days with a decision. If the agency determines that the research does not need an IND, it will issue a statement to that effect. If the FDA considers an IND necessary, it may grant an IND or follow up for more information.
If a medical device is being evaluated in the research and is FDA-approved (has a premarket approval number), cleared (has a 510(k) number) or is a Class I or Class II device exempted from premarket review and is being used in the research in a way that matches the indications on the FDA documentation, provide the approval/exemption information.
If your device meets another exemption under the investigational device exemption (IDE) regulations, provide a rationale for why your device qualifies as IDE-exempt.
Otherwise, if the device is investigational, the IRB must make specific determinations related to the risk of the device and whether an IDE or abbreviated IDE is required. You can either propose with a rationale why the device meets the abbreviated IDE requirements as the use does not present a significant risk or obtain documentation from FDA.
There are two ways to ask FDA about potential or planned medical device studies. The first is to submit a study risk determination request to the agency. The FDA will give a written response documenting its determination. The other way is to apply for an IDE. By law, the FDA must respond to an IDE application within 30 days with a decision. If the agency determines that a device study does not carry significant risk, it will issue a statement to that effect. The FDA may issue an IDE or follow up for questions.
For investigational combination products, provide an FDA letter for the test articles with the IND or IDE number.
For human cells, tissue, and cellular and tissue-based products (HCT/P), consult the following FDA guidances to ensure that your product is regulated solely as a Section 361 HCT/P product and meets all the criteria stated in 21 CFR 1271.10(a) (1) to (4):
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