Contacting the FDA

We strongly advise reviewing the below information & contacting the ICTR IND/IDE team before reaching out to the FDA on your own.

Working with our IND/IDE team is the most efficient way for an investigator to navigate this important process and minimize unnecessary steps.

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As always, the ICTR IND/IDE team is ready and able to help you navigate the process of contacting the FDA.

Please click here to request assistance!

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Meetings with the FDA

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Communication with FDA During the Drug Development and pre-IND Process

A pre-IND meeting is classified as a Type B meeting. It is a formal written request for feedback from the FDA, to be provided in writing or through a meeting or teleconference.

A Type B meeting is appropriate when FDA’s feedback on specific questions is necessary to guide product development or application preparation.

A Type B meeting is not required and is entirely voluntary, but is strongly encouraged when specific questions arise that are not adequately addressed by existing guidance.

Meetings with the FDA - IND

A Type B meeting is useful for early feedback in the following areas:

  • Regulatory (e.g., plans for submission of proprietary name requests, plans to defer or waive specific studies, development plans with other FDA centers (e.g., the Center for Devices and Radiological Health) for combination products, applicability of an expedited program.
  • Clinical/statistical (e.g., planned clinical trials to support effectiveness, validity of outcomes and endpoints, trial size, enrichment designs)
  • Safety (e.g., safety issues identified in nonclinical studies and early clinical trials, size of the overall safety database, concerns related to particular populations, post-approval pharmacovigilance plans, risk evaluation and mitigation strategies, plans for human factors studies, issues related to evaluation of abuse potential)
  • Clinical pharmacology and pharmacokinetics (e.g., dose selection, use in specific populations, drug-drug interactions)
  • The ICTR IND/IDE team can help you navigate these meetings & requirements. Click here to request help.

Guidance

The following excellent guidance documents provide information on:

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The Pre-Submission Program for Medical Devices (IDE)

A Pre-Submission (Pre-Sub) is a formal written request for feedback from the FDA, to be provided in writing or through a meeting or teleconference.

A Pre-Sub is appropriate when FDA’s feedback on specific questions is necessary to guide product development or application preparation.

A Pre-Sub is not required and is entirely voluntary, but is strongly encouraged when specific questions arise that are not adequately addressed by existing guidance.

Meetings with the FDA - IDE

A Pre-Sub is useful for early feedback for the following example circumstances:

  • The new device involves novel technology and it may be helpful to familiarize the FDA review team with the technology in advance of the submission.
  • you are proposing a “first of a kind” indication or a new indication for an existing device.
  • the new device does not clearly fall within an established regulatory pathway, and you desire informal input on a proposed regulatory strategy.
  • you desire FDA guidance on specific issues related to nonclinical study protocols and/or animal study protocols, before initiating your studies.
  • you desire FDA input on specific issues related to your planned clinical studies, especially if they involve complex or novel statistical approaches.
  • The ICTR IND/IDE team can help you navigate these meetings & requirements. Click here to request help.

Guidance

FDA has provided excellent guidance on the Pre-Sub process for Medical Device Submissions, available here.

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Preparing for an Inspection by the FDA

If you are contacted by the FDA and notified that your study will undergo an inspection, the following steps are required: