Regulatory Applications
Regulatory Submissions for Sites
It is the responsibility of the Site PI to submit the protocol and all accompanying documentation to the IRB and any other required entities for review. For all information regarding submissions, including what needs to be submitted, IRB forms, review or submission support, and IRB fees for certain studies, visit the Penn IRB website.
For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.
Regulatory Submissions for Sponsors
US Trial
Sponsors who are developing investigator-initiated protocols should follow the steps outlined here for studies to be conducted in the US.
International Trial
If you are conducting clinical trials outside of the US, trial requirements will differ by country. Reference Step 4 and contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.
For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.
The FDA regulates a wide range of products, including foods, drugs, vaccines and other biological products, medical devices, radiation-emitting products, cosmetics, dietary supplements, and tobacco products. The regulations are defined in the Code of Federal Regulations (CFR), Title 21 Food and Drugs.
The first step is determining the product’s category and the associated requirements. If you have developed the product, please first review Product Development. For further guidance or questions that are not addressed on this page, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.
What is a Drug?
A drug is a substance that is:
Biological products are included within this definition and generally follow the same laws and regulations, with some differences regarding their manufacturing processes. References: |
What is a Medical Device? *
* Certain software and mobile medical apps, including those using artificial intelligence and/or machine learning algorithms, can also fall under the medical device regulations. The FDA’s Digital Health Policy Navigator may be a helpful tool.
References:
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After determining that you are using a drug or medical device, you need to know the regulatory requirements that apply to your clinical trial. Drug regulations can be found in [21 CFR 312] and device regulations can be found in [21 CFR 812]. For further guidance, please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu. Some reviews of drugs and devices may be deferred to the FDA or may have a requirement for FDA review (i.e. certain grants); see step 5 for additional details.
Drugs and the IND RegulationsDrug studies may fall into two categories:
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Medical Devices and the IDE RegulationsMedical device studies may fall into several different categories:
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It is possible that you may have or may develop Intellectual Property (IP) over the course of the clinical trial. Consultation and close communication with the Penn Center for Innovation is essential to protecting your IP.
For further guidance, please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu.
If it has been determined that your clinical trial requires an IND or IDE application, or an international clinical trial application, please complete the Sponsor Registration Survey, as indicated in PSOM SOP006.
Additionally, many trials will require posting on ClinicalTrials.gov. Please reference additional guidance here.
For further guidance, please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu.
In many cases, review by OCR or another Penn reviewing entity will be sufficient. However, in some cases, a submission to the FDA will be needed.
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Drugs (includes biologics, food, dietary supplements) |
Devices |
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IND Exemption Request Some exemption requests may need to be reviewed by the FDA. There are templates and submission instructions available. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.
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IDE Exemption Request Some exemption requests may need to be reviewed by the FDA. There are templates and submission instructions available. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.
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IND Application Pre-Submission Feedback There are mechanisms available to obtain feedback from the FDA prior to submission of an IND application (pre-IND meeting).
The FDA has a detailed guidance regarding the different types of meetings that may be requested, the request process, and timelines. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu for additional guidance. |
IDE Application Pre-Submission Feedback There are mechanisms available to obtain feedback from the FDA prior to submission of an IDE application through the Q-submission process. The FDA has a detailed guidance regarding Pre-IDE Meeting requests, the request process, and timelines. Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu for additional guidance.
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IND Application On the OCR website, you can find the following templates and instructions: · IND Application Template with instructions · Instructions for Submitting to the FDA
The FDA also has an extensive website for Investigator Initiated Investigational New Drug (IND) Application.
FDA often has questions during the 30-day review period, and often there are short response deadlines. This should be taken into account prior to submission.
Please contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.
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Abbreviated IDE (aIDE) Application If you have a non-significant risk device, you will need to complete an aIDE application and submit it to the IRB. In certain cases, you may need to submit the aIDE application to the FDA.
Please reference the IRB website for additional details and contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.
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Full IDE (IDE) Application If you have a significant risk device, you will need to complete the full IDE application and submit it to the FDA.
The FDA also has an informative website for preparing IDE Applications and has templates and instructions on the submission process.
FDA often has questions during the 30-day review period, and often there are short response deadlines. This should be taken into account prior to submission.
Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu for additional guidance.
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FDA Review Timelines IND exemption request – generally 30 days
IND pre-submission – varies based on type of submission, refer to FDA guidance
IND application – 30 days |
FDA Review Timelines IDE exemption request – 30-90 days, depending on submission mechanism
IDE pre-submission – varies based on type of submission, refer to FDA guidance
IDE application – generally 30 days
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