Regulated Products and Devices: Additional Requirements
Studies that propose the use of U.S. Food and Drug Administration (FDA)- or U.S. Drug Enforcement Administration (DEA)-regulated products and devices must complete the National Center for Complementary and Integrative Health (NCCIH) Regulatory Tracking Form with details about the Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or DEA-controlled substance. This form should be submitted to the National Center for Complementary and Integrative Health (NCCIH) program director (PD) once all pertinent information and supportive documentation are available, and before beginning recruitment.
NCCIH Regulatory Tracking Form [266 KB PDF]
NCCIH Natural Product Integrity Policy (PIP): NCCIH requires information on each product including placebo, if applicable, proposed for use in your study. If you have been notified that a PIP is required for your study, carefully review Section III and Section IV in NCCIH Policy: Natural Product Integrity for a complete description of this process and the requested information. Do not upload this information with other Just In Time documents. This information should be submitted electronically as a PDF document via email to email@example.com.
The information requested is dependent on the type of product and research involved. Please determine the section that corresponds to your application and respond explicitly and separately to each item. If the information is not available or not applicable, state “information not available or not applicable,” and provide an explanation. Prepare separate responses for each study agent, including placebo, if applicable, following the appropriate guidance for the product category.
NCCIH staff, with input from selected external experts, as needed, will evaluate this information to confirm your study agent(s) are properly identified, well characterized, and sufficiently monitored. NCCIH will provide you with an evaluation of your responses to the items requested in the policy. If necessary, you will have the opportunity to address any unresolved questions.
FDA: The FDA has the sole responsibility for decisions regarding both IND and IDE applications. NCCIH should be kept up to date regarding the status of your IND or IDE application.
- IND: If the proposed work involves use of a bioactive ingredient in humans, you must contact the FDA to determine whether an IND is required for your study. In addition to submission of the NCCIH Regulatory Tracking Form, you must provide written documentation from the FDA to your PD regarding whether an IND submission is required. NCCIH strongly recommends that you discuss the overall study design with your PD prior to submitting the IND to the FDA. In addition, you must submit to your PD a copy of the FDA acknowledgment letter for your IND submission, as well as subsequent letters you receive from the FDA regarding any clinical hold of the proposed NCCIH-funded studies.
- IDE: If the clinical study uses a medical device as part of the intervention that is not legally marketed in the United States, you must contact the FDA for determination as to whether an IDE application will be needed for the study. In addition to submission of the NCCIH Regulatory Tracking Form, you must submit to your PD a copy of the FDA acknowledgment letter for your IDE application, as well as subsequent letters you receive from the FDA regarding the proposed NCCIH-funded studies.
- Controlled Substance: If the clinical study will use a product controlled by the DEA (Controlled Substances Act [CSA] Schedules I–V) as part of the investigation, the principal investigator will complete the NCCIH Regulatory Tracking Form documenting the planned use of controlled substance(s) and list the responsible individuals and facilities associated with use. Research on CSA Schedule I drugs requires site-specific DEA investigator registration (see 21 CFR 1301.18). There is an application fee. Renewal is required annually. For information on how to apply visit: https://www.deadiversion.usdoj.gov/drugreg/process.htm.