Penn Medicine Clinical Research

Regulatory Applications

Regulatory Submissions for Sites

It is the responsibility of the Site PI, or delegated team member(s), to submit the protocol and all accompanying documentation to the Penn IRB, or other relied upon IRB, for review. For all information regarding submissions, what needs to be submitted and does not, IRB fees, IRB forms and review or submission support, visit the Penn IRB website

Regulatory Submissions for IIT FDA Sponsors

The following are the steps for sponsors that are writing and developing their investigator initiated protocol. These are the requirements for drug and medical device clinical trials.

If you are conducting clinical trials outside of the United States, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu. Trial requirements will differ by country.

The FDA regulates a wide range of products, including foods, human and veterinary drugs, vaccines and other biological products, medical devices intended for human use, radiation-emitting electronic products, cosmetics, dietary supplements, and tobacco products. The regulations are defined in the Code of Federal Regulations (CFR), specifically Title 21 Food and Drugs.  There are specific regulations that apply to research with human participants and this page will cover the fundamental information needed to conduct an investigator initiated clinical trial with an FDA-regulated product.

The first step in the process is determining if the product you are using and the way in which you are using it meets the definition of a drug or medical device. If you have developed the product please first review Product Development.  For guidance, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.

Drug Defined

The FDA defines a drug, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Refer to Drugs@FDA Glossary of Terms.

For additional information please see the Penn IRB Research with Drug Products.

Medical Device Defined

The FDA defines a medical device as:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

Certain software and mobile medical apps, including those using artificial intelligence and/or machine learning algorithms, can also fall under the medical device regulations. Please see the link above for more information.

For more information, please see the UPenn Research with Device Products, the FDA website “How to Determine if Your Product is a Medical Device”, and “How do I Determine if my Product is a Medical Device.”

Drug or Medical Device

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

Drugs and the IND Regulations

Drug studies may fall into two categories:

  • IND exempt or
  • IND application required

IND Exemption Flow Chart

Medical Devices and the IDE Regulations

Medical device studies may fall into several different categories:

  • Part 812 doesn’t apply
  • FDA Enforcement Discretion
  • IDE Exempt
  • Not IDE Exempt, presenting non-significant risk (Abbreviated IDE application)
  • Not IDE Exempt, presenting significant risk (Full IDE application)

IDE Exemption Flow Chart

 

 

If it has been determined that your clinical trial requires an IND or IDE application, please complete the Sponsor Registration Survey, as indicated in PSOM SOP006.

When conducting research with drugs or medical devices, it is possible that you may have or develop Intellectual Property (IP) over the course of the clinical trial.  Therefore, consultation and close communication with the Penn Center for Innovation is essential to protecting your IP.

Additionally, many trials will require posting on ClinicalTrials.gov. Please reference additional guidance here.

Now that you have become familiar with the regulatory requirements for your clinical trial, you can begin putting together your regulatory exemption request or application.

Exemption Requests

The OCR Regulatory team can evaluate your protocol for applicability of IND and/or IDE Exemption requirements. If needed, the OCR Regulatory team can also support you in preparing an exemption request to the FDA.  Please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.

Drug: IND Applications and pre-submission feedback with the FDA

Pre-Submission Feedback

There are mechanisms available to obtain feedback from the FDA prior to submission of an IND application, which include meetings prior to submission of an IND application (pre-IND meetings).

The FDA has a detailed guidance document regarding the different types of meetings that may be requested, the request process, and timelines. For any questions or further guidance, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.

IND Application

The OCR Regulatory team can assist you with preparing your IND Application. On the OCR website, you can find the following templates and instructions:

The FDA also has an extensive website for Investigator Initiated Investigational New Drug (IND) Applications.

Please contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.

IND Application Timeline

After an IND application is submitted, the FDA has 30 days to review your application. You may proceed with your clinical trial if:

  • The FDA has indicated you may proceed, OR
  • 30 days have passed, and you have not heard back from the FDA.

Often, the FDA will contact you with questions during this 30-day review period. Please note that FDA questions during this period will have response deadlines that are often short. You should be available during this time, even if another person on your team is the main contact with the FDA.

Device: IDE Applications and pre-submission feedback from the FDA

Pre-Submission Feedback

There are mechanisms available to obtain feedback from the FDA prior to submission of an IDE application through the FDA Q-submission process.

The FDA has an extensive guidance available that can be used for Pre-IDE Meeting requests: Requests for Feedback and Meeting for Medical Device Submission: The Q-Submission Program.

For assistance, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.

Abbreviated IDE Application

If you plan to submit an abbreviated IDE application (non-significant risk device), there is no requirement to submit to the FDA; however, the abbreviated IDE application will be submitted to the IRB. On the OCR website, you can find the following template and instructions:

Please reference the IRB website for additional details and contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.

Full IDE Application

The OCR Regulatory team can assist you with preparing your IDE Application. On the OCR website, you can find the following template and instructions: IDE Application Template

The FDA also has an informative website for preparing IDE Applications. and has templates, as well as work instructions on how to submit your application.

Please contact OCR Regulatory at psom-ind-ide@pobox.upenn.edu for additional guidance.

Full IDE Application Timeline

After an IDE application is submitted, FDA has 30 days to review your application. You may proceed with the clinical trial only once the FDA approves your application.

Often, the FDA will contact you with questions during this 30-day review period. Please note that FDA questions during this period will have response deadlines that are often short. You should be available during this time, even if another person on your team is the main contact with the FDA.